Clinical trial NCT03764475
Conditions: Plaque Psoriasis
Sponsor: Arcutis Biotherapeutics, Inc.
Start date: 2018-12-18; Completion date: 2020-10-08
Enrollment: 332 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Detailed description:
Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201 (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in ARQ-151-201.

Arms: arm 1: Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 52 weeks
Interventions: intervention 1: Roflumilast
Intervention descriptions: intervention 1: Roflumilast cream 0.3% for topical application

Protocol documents:
Prot_000.pdf: 
 
 
Study 
Number: 
ARQ-151-202 
NCT #: 
NCT03764475 
Official 
Title: 
A Phase 2, Multicenter, Open-Label Extension 
Study of the Long-Term Safety of ARQ-151 
Cream 0.3% in Adult Subjects With Chronic 
Plaque Psoriasis Who Have Completed 
Preceding Study ARQ-151-201 Phase 2 
Randomized Controlled Trial (Cohort 1) and 
Non-ARQ-151-201 Subjects (Cohort 2) 
Protocol 
Date: 
12-Apr-2019 
 


April 12, 2019 
Confidential 
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Protocol ARQ-151-202 
A Phase 2, Multicenter, Open-Label Extension Study of the 
Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects 
with Chronic Plaque Psoriasis who have Completed Preceding 
Study ARQ-151-201 Phase 2 Randomized Controlled Trial 
(Cohort 1) and non-ARQ-151-201 Subjects (Cohort 2) 
 
 
ORIGINAL ISSUE DATE: 
November 21, 2018 
AMENDMENT 1: 
April 12, 2019 
 
 
 
 
GCP Statement 
This study is to be performed in full compliance with the protocol, Good Clinical Practices 
(GCP), and applicable regulatory requirements. All required study documentation will be 
archived as required by regulatory authorities. 
 
Confidentiality Statement 
This document is confidential. It contains proprietary information of Arcutis, Inc. Any 
viewing or disclosure of such information that is not authorized in writing by Arcutis, Inc. is 
strictly prohibited. Such information may be used solely for the purpose of reviewing or 
performing this study. 


 
 
Study 
Number: 
ARQ-151-202 
NCT #: 
NCT03764475 
Official 
Title: 
A Phase 2, Multicenter, Open-Label Extension 
Study of the Long-Term Safety of ARQ-151 
Cream 0.3% in Adult Subjects With Chronic 
Plaque Psoriasis Who Have Completed 
Preceding Study ARQ-151-201 Phase 2 
Randomized Controlled Trial (Cohort 1) and 
Non-ARQ-151-201 Subjects (Cohort 2) 
Protocol 
Date: 
12-Apr-2019 
 






Protocol ARQ-151-202 Amendment 1 
Arcutis, Inc. 
 
 
 
April 12, 2019 
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PROTOCOL REVISION HISTORY 
Version/Date 
Description 
ARQ-151-202 Version 1 
November 21, 2018 
Original protocol 
ARQ-151-202 Amendment 1 
April 12, 2019 
 Added protocol revision history section 
 Updated Sponsor address 
 Added I-IGA and mPASI to secondary endpoints 
throughout 
 Added Cohort 2 (non ARQ-151-201) subjects 
throughout 
 Added phone visits at Weeks 18, 30 and 44 and added 
instructions for the subject to call the site prior to 
restarting study medication  
 Added additional inclusion and exclusion criteria for 
Cohorts 1 and 2  
 Updated exclusion criteria to exclude moderate to 
severe liver impairment (Child-Pugh B or C) 
 Added Screening visit for non-ARQ-151-201 subjects 
including the Screening C-SSRS 
 Added Table 2, Wash out period for Medications and 
Treatments for Cohort 2 
 Added Appendix 1 Columbia-Suicide Severity Rating 
Scale (C-SSRS) Baseline/Screening Version 
 Updated Columbia-Suicide Severity Rating Scale (C-
SSRS) Since Last Visit Version to Appendix 2 and 
updated National Institute of Allergy and Infectious 
Diseases, Division of Microbiology and Infectious 
Diseases (DMID) Toxicity Table for Use in Trials 
Enrolling Healthy Adults (2014) Modified to 
Appendix 3 
 Editorial and administrative changes throughout the 
protocol to clarify language and formatting to improve 
readability. 
 
 
 




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3 
TABLE OF CONTENTS 
 
1 
PRINCIPAL INVESTIGATOR AND SPONSOR – SIGNATORIES ............................. 2 
2 
KEY CONTACTS FOR THE STUDY ............................................................................... 5 
3 
TABLE OF CONTENTS ..................................................................................................... 6 
4 
SYNOPSIS ........................................................................................................................... 10 
5 
SCHEDULE OF VISITS AND ASSESSMENTS ............................................................ 15 
6 
ABBREVIATIONS ............................................................................................................. 17 
7 
BACKGROUND AND RATIONALE .............................................................................. 19 
7.1 
Introduction ................................................................................................................. 19 
7.2 
Preclinical Studies ....................................................................................................... 19 
7.2.1 Repeat-Dose Toxicity ............................................................................................... 20 
7.2.2 Oral (Systemic) Studies of Roflumilast and N-Oxide Metabolite ............................ 21 
7.2.3 Reproductive Toxicity .............................................................................................. 22 
7.2.4 Genotoxicity .............................................................................................................. 22 
7.2.5 Carcinogenicity ......................................................................................................... 22 
7.2.6 Special Toxicity:  Local Tolerance of Topical Formulation ..................................... 23 
7.2.7 Conclusions on Toxicity Findings ............................................................................ 23 
7.3 
Clinical Studies ............................................................................................................ 24 
7.3.1 Topical Roflumilast Cream ....................................................................................... 24 
7.3.2 Phase 1/2a Study of Topical ARQ-151 Cream ......................................................... 24 
7.3.3 Phase 2b Study of Topical ARQ-151 Cream ............................................................ 26 
7.3.4 Oral Roflumilast Tablet ............................................................................................ 27 
7.4 
Rationale for Development......................................................................................... 27 
7.4.1 Dose Selection .......................................................................................................... 28 
7.4.2 Risks and/or Benefits to Subjects ............................................................................. 28 
8 
STUDY OBJECTIVE AND ENDPOINTS ....................................................................... 28 
8.1 
Study Objective ........................................................................................................... 28 
8.2 
Study Endpoints .......................................................................................................... 29 
8.2.1 Primary Endpoint ...................................................................................................... 29 
8.2.2 Secondary Endpoints ................................................................................................ 29 
9 
INVESTIGATIONAL PLAN ............................................................................................ 29 
9.1 
Overall Study Design and Plan .................................................................................. 29 
9.2 
Subject Participation .................................................................................................. 30 
9.3 
Randomization ............................................................................................................ 30 
9.4 
Numbering of Subjects ............................................................................................... 30 
9.5 
Blinding ........................................................................................................................ 30 


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9.6 
Selection of Patient Population .................................................................................. 30 
9.6.1 Inclusion Criteria ...................................................................................................... 30 
9.6.2 Exclusion Criteria ..................................................................................................... 31 
9.6.3 Removal of Subjects from the Study ........................................................................ 32 
9.7 
Study Restrictions ....................................................................................................... 33 
9.7.1 Prohibitions and Concomitant Therapy .................................................................... 33 
9.8 
Investigational Product and Treatment .................................................................... 35 
9.8.1 Drug Supplies, Packaging and Labeling ................................................................... 35 
9.8.2 Treatment Administration ......................................................................................... 35 
9.8.3 Treatment Compliance .............................................................................................. 35 
10 STUDY PROCEDURES .................................................................................................... 36 
10.1 
Safety Assessments ...................................................................................................... 36 
10.1.1 
Physical Examination............................................................................................ 37 
10.1.2 
Vital Signs, Height and Weight ............................................................................ 37 
10.1.3 
12-lead ECGs ........................................................................................................ 37 
10.1.4 
Laboratory Tests ................................................................................................... 37 
10.1.5 
Patient Health Questionnaire depression scale (PHQ-8) ...................................... 38 
10.1.6 
Columbia-Suicide Severity Rating Scale (C-SSRS) ............................................. 39 
10.1.7 
Local Tolerability Assessments ............................................................................ 40 
10.1.8 
Adverse Events ..................................................................................................... 41 
10.1.9 
Phone Visits .......................................................................................................... 41 
10.2 
Efficacy Evaluations ................................................................................................... 41 
10.2.1 
Investigator’s Global Assessment (IGA) .............................................................. 41 
10.2.2 
Modified Psoriasis Area and Severity Index (mPASI) ......................................... 43 
10.2.3 
Body Surface Area (BSA) .................................................................................... 44 
10.3 
Final Study Visit – End of Study ............................................................................... 44 
10.4 
Early Termination Visit ............................................................................................. 44 
10.5 
Unscheduled Visit........................................................................................................ 44 
10.6 
Adverse Events ............................................................................................................ 45 
10.6.1 
Adverse Event Definition ..................................................................................... 45 
10.6.2 
Serious Adverse Event .......................................................................................... 45 
10.6.3 
Suspected Unexpected Serious Adverse Reaction (SUSAR) ............................... 47 
10.6.4 
Safety Review ....................................................................................................... 47 
10.6.5 
Adverse Event Reporting ...................................................................................... 47 
10.7 
Reporting Pregnancy .................................................................................................. 48 
10.8 
Treatment Stopping Rules ......................................................................................... 49 
11 DATA ANALYSIS .............................................................................................................. 50 
11.1 
Statistical Methods ...................................................................................................... 50 
11.1.1 
Baseline Definition ............................................................................................... 50 
11.1.2 
Determination of Sample Size .............................................................................. 51 
11.1.3 
Subjects to Analyze............................................................................................... 51 


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11.1.4 
Interim Analysis .................................................................................................... 51 
11.1.5 
Background and Demographic Characteristics ..................................................... 51 
11.1.6 
Study Medication Compliance .............................................................................. 51 
11.2 
Safety Evaluation ........................................................................................................ 51 
11.2.1 
Adverse Events ..................................................................................................... 51 
11.2.2 
Medical History and Physical Examinations ........................................................ 52 
11.2.3 
Clinical Laboratory Results and Vital Signs/Weight Measurements ................... 52 
11.2.4 
ECG: ..................................................................................................................... 52 
11.2.5 
Local Tolerance Assessments: .............................................................................. 53 
11.2.6 
PHQ-8 ................................................................................................................... 53 
11.2.7 
C-SSRS ................................................................................................................. 53 
11.2.8 
Prior and Concomitant Medications ..................................................................... 53 
11.3 
Efficacy Evaluation ..................................................................................................... 53 
12 STUDY ADMINISTRATION ........................................................................................... 54 
12.1 
Ethics ............................................................................................................................ 54 
12.1.1 
Ethics Review Board............................................................................................. 54 
12.1.2 
Ethical Conduct of the Study ................................................................................ 54 
12.1.3 
Subject Information and Consent.......................................................................... 55 
12.2 
Study Monitoring ........................................................................................................ 55 
12.3 
Data Quality Assurance .............................................................................................. 55 
12.4 
Data Handling and Record Keeping ......................................................................... 55 
12.5 
Protocol Amendments and Deviations ...................................................................... 56 
12.6 
Report Format ............................................................................................................. 56 
12.7 
Publication Policy........................................................................................................ 56 
13 REFERENCES .................................................................................................................... 57 
14 APPENDICES ..................................................................................................................... 58 
 
 
LIST OF TABLES 
Table 1.  Excluded Medications and Treatments .................................................................... 34 
Table 2.  Wash Out Period for Medications and Treatments (Cohort 2) ................................ 34 
 
 
LIST OF FIGURES 
Figure 1.  TPSS x TPA Fitted Summary Statistics from MMRM (mITT Population) ........... 25 
 
 
 
 


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LIST OF APPENDICES 
Appendix 1. Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version .............................................................................................................. 58 
Appendix 2. Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit 
Version .............................................................................................................. 60 
Appendix 3. National Institute of Allergy and Infectious Diseases, Division of 
Microbiology and Infectious Diseases (DMID) Toxicity Table for Use 
in Trials Enrolling Healthy Adults (2014) Modified......................................... 63 
 
 


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4 
SYNOPSIS 
Compound 
ARQ-151 cream 0.3%  
IND 
135,681 
Clinical 
Indication 
Chronic Plaque Psoriasis 
Study Phase and 
Type 
 Phase 2 (2b)  
 52 week, long-term safety study of ARQ-151 cream 0.3% 
Study Objectives 
To assess long-term safety in a multicenter, open-label, 52-week study 
in subjects treated with ARQ-151 cream 0.3% after completing a 12-
week Phase 2b study (ARQ-151-201) Cohort 1 and non-ARQ-151-201 
subjects (Cohort 2). 
Study Endpoints 
Primary Endpoints 
 Occurrence of treatment emergent AEs (TEAEs) 
 Occurrence of Serious Adverse Events (SAEs)  
 
Secondary Endpoints 
 Proportion (%) of subjects achieving an Investigator Global 
Assessment (IGA) of clear or almost clear, as observed at 
Week 12 and subsequent scheduled visits.  
 Proportion (%) of subjects who achieve 'clear' IGA, I-IGA (if 
applicable) and mPASI (Modified Psoriasis Area Severity 
Index) score and stop treatment to all lesions, time to re-starting 
study drug (duration of response). 
 Proportion (%) of applicable subjects with intertriginous area 
involvement, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at week 
12 and subsequent visits. 
 Proportion of subjects who achieve a 75% reduction in mPASI 
at Week 12 and subsequent scheduled visits as compared to 
baseline.  
Summary of 
Study Design 
Open-label, long-term safety study of ARQ-151 cream 0.3% in 
subjects with chronic plaque psoriasis involving up to 25% total BSA. 
Cohort 1 eligible subjects will enroll into the long-term safety study on 
the same day as the Week 12 visit for the previous study 
(ARQ-151-201). Cohort 2 eligible subjects will enroll on Day 1 of this 
study. Study medication will be applied by the qualifying subjects 
topically QD for 52 weeks at home. Periodic clinic visits will include 
assessments for clinical safety, application site reactions evaluated in 
the clinic using the method of Berger and Bowman, and disease 
improvement or progression.  
 


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Blinding 
 This study is open label 
 All participants will receive ARQ-151 cream 0.3% 
Countries: 
United States and Canada 
Number of sites 
Approximately 30 sites  
Study Population 
Subjects who have completed the 12 week treatment period in study 
ARQ-151-201 and are willing to enroll in this 52-week extension study 
(Cohort 1) and qualified non-ARQ-151-201 subjects (Cohort 2).  
Inclusion Criteria 
All Subjects 
1. Participants legally competent to sign and give informed consent 
2. Males and females ages 18 years and older  
3. Females of childbearing potential (FOCBP) must have a negative 
urine pregnancy test at  all study visits. In addition, sexually active 
FOCBP must agree to use at least one form of highly effective 
contraception throughout the trial.  Highly effective forms of 
contraception include: oral/implant/injectable/transdermal 
contraceptives, intrauterine device, or partner’s vasectomy.  If 
barrier methods are used (e.g., condom with spermicide, diaphragm 
with spermicide), then 2 forms of conception are required. The use 
of abstinence as a contraceptive measure is acceptable as long as 
this is a consistent part of a lifestyle choice and a backup method 
has been identified if the subject becomes sexually active. 
4. Post-menopausal women with spontaneous amenorrhea for at least 
12 months or have undergone surgical sterilization (permanent 
sterilization methods include hysterectomy, bilateral 
oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or 
bilateral salpingectomy). 
Inclusion Criteria  
Cohort 1 Only 
5. Subjects with chronic plaque psoriasis who met eligibility criteria 
for ARQ-151-201, successfully completed ARQ-151-201 through 
Week 12, and are able to enroll into this long-term safety study on 
the Week 12 visit of the previous study (ARQ-151-201). 
Inclusion Criteria 
Cohort 2 Only 
6. Clinical diagnosis of psoriasis vulgaris of at least 6 months 
duration as determined by the Investigator. 
7. Psoriasis vulgaris on the face, extremities, trunk, and/or 
intertriginous areas involving 2% to 25% of BSA (excluding the 
scalp, palms and soles). 
8. An Investigator's Global Assessment of disease severity (IGA) of at least 
Mild ('2') at Day 1. 
Exclusion Criteria 
All Subjects 
1. Subjects that use any Excluded Medications and Treatments (see 
Table 1). 
2. Subjects currently taking lithium or antimalarial drugs. 
3. Planned initiation or changes to concomitant medication that could, 




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16. Subjects who are unable to communicate, read or understand the 
local language, or who display another condition, which in the 
Investigator’s opinion, makes them unsuitable for clinical study 
participation. 
Exclusion Criteria 
Cohort 1 Only 
17. Subjects who experienced an ARQ-151 treatment-related AE or a 
serious AE (SAE) that precluded further treatment with ARQ-151 
cream in Study ARQ-151-201. 
Exclusion Criteria 
Cohort 2 Only 
18. Subjects who cannot discontinue medication and treatments  prior 
to the Day 1 visit according to Excluded Medications and 
Treatments (Table 2). 
Number of 
Subjects 
Up to approximately 300 subjects (Cohort 1) 
Up to approximately 100 subjects (Cohort 2) 
Duration of 
Participation for 
Subjects 
Approximately 52 weeks  
Study Products 
ARQ-151 drug product will be supplied as a 0.3% cream in a 
squeezable tube. 
Planned Dose 
Level 
 Subjects with up to 25% total BSA of psoriatic lesions will receive 
ARQ-151 cream 0.3% to be applied QD topically to all lesions. 
 Application will be to all areas affected including the face and 
intertriginous/genital regions (except for the scalp). 
 Subjects may stop treatment to lesions/areas that have cleared and 
completely resolved. Treatment may resume in these or new areas 
should psoriatic lesions emerge during the study. 
 If treatment is judged by the Investigator as being ineffective, then 
the subject may be withdrawn from the study at any time.  
Safety 
Assessments 
Safety will be monitored through application site assessments in  the 
clinic using the method of Berger and Bowman, clinical laboratory 
testing, 12-lead ECGs, PHQ-8, C-SSRS and AEs. 
Safety Analysis 
Adverse Events 
A subject-by-subject treatment-emergent AE (TEAE) data listing, 
including verbatim term, preferred term, treatment, severity, and 
relationship to study drug, will be provided. 
The number of subjects experiencing AEs and number of AEs will be 
summarized by treatment using frequency counts. 
Physical Examinations 
Vital signs will be collected at all study visits. Physical examinations 
and 12-lead ECGs will be collected periodically throughout the study.  
Clinical Laboratory Results 
Routine blood chemistries will be obtained at all study visits. Urine 


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pregnancy tests will be collected periodically throughout the study. 
Patient Health Questionnaires 
PHQ-8 and C-SSRS questionnaires will be completed by the subjects 
at all study visits. Descriptive statistics will be calculated for the PHQ-
8. The C-SSRS will be analyzed per the Scoring and Data Analysis 
Guide from the Columbia Lighthouse Project. 
Efficacy Analysis 
The efficacy endpoints will be defined as:  
 Proportion (%) of subjects achieving an Investigator Global 
Assessment (IGA) of clear or almost clear, as observed at 
Week 12 and subsequent scheduled visits.   
 In subjects who achieve 'clear' IGA, I-IGA and MPASI scores 
and stop treatment to all lesions, time to re-starting study drug 
(duration of response) 
 Proportion (%) of applicable subjects with intertriginous area 
involvement, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at week 
12 and subsequent visits 
 Proportion (%) of subjects achieving a 75% reduction from 
Baseline of Modified Psoriasis Area Severity Index-75 
(mPASI-75) at weeks 12, 24, 36 and 52 as compared to 
Baseline. 
Power and 
Sample Size 
Up to approximately 300 subjects are planned for Cohort 1 and up to 
approximately100 subjects are planned for Cohort 2.   
The sample size will provide a sufficient population size to evaluate 
the long-term safety of ARQ-151 cream 0.3% at 52 weeks. 
Statistical 
Analysis: 
This study is not intended to assess efficacy, but rather the IGA, I-IGA 
and mPASI are included to determine the need for treatment and 
subsequent re-treatment after treatment course in Study ARQ-151-201 
or Study ARQ-151-202.  Certain efficacy data and endpoints will, 
however, be summarized. 
Descriptive statistics will be presented for the endpoint data collected 
in the clinical trial. For analysis of the proportion (%) of subjects 
achieving an IGA of clear or almost clear at week 52, as observed, no 
imputation for missing data will be performed. The proportion of 
successes for the secondary variables of I-IGA and 75% reduction in 
mPASI will be tabulated. 
The duration of response will be analyzed using the Kaplan-Meier 
method. 
No formal inferential statistics will be performed on safety 
assessments. Descriptive statistics will be calculated for quantitative 
safety data and frequency counts will be compiled for classification of 
qualitative safety data.   
 


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5 
SCHEDULE OF VISITS AND ASSESSMENTS 
STUDY EVENTS FLOW CHART: 
 
Study Procedure 
Washout 
Cohort 2 
Day 1 
(Cohort 
2) 
Wk 4 Wk 
12 
 
Wk  
18 
Wk 24 
 
Wk 
30 
Wk 
36 
 
Wk 
44 
Wk 
52 
Visit 
Screening 
Visit 7 
(Week 12) 
of ARQ-
151-201 
Study 
(Cohort 
1) 
1 
2 
Phone 
Visit 
3 
Phone 
Visit 
4 
Phone 
Visit 
5 
Visit Window 
-35 days 
+/- 3 
days 
+/- 5 
days 
 
 
+/- 7 
days 
+/- 7 
days 
 
 
+/- 7 
days 
+/- 7 
days 
 
 
+/- 7 
days 
+/- 7 
days 
Informed consent 
Xi 
Xi 
 
 
 
 
 
 
 
 
Physical examinationa 
 
Xh 
 
 
 
X 
 
 
 
X 
I/E criteria 
X 
X 
 
 
 
 
 
 
 
 
Hematology, Serum 
Chemistries, and Urine 
Analysis  
X 
Xh 
X 
X 
 
X 
 
X 
 
X 
12 lead ECG 
X 
Xh 
 
 
 
X 
 
 
 
X 
Vital signs, height, weightb 
 
Xh 
X 
X 
 
X 
 
X 
 
X 
IGAc, I-IGA, mPASI and 
BSAc 
X 
Xh 
X 
X 
 
X 
 
X 
 
X 
C-SSRS, PHQ-8  
X 
 Xh 
X 
X 
 
X 
 
X 
 
X 
Urine pregnancy testd 
X 
Xh 
X 
X 
 
X 
 
X 
 
X 
Local Tolerability 
Assessmente 
 
Xh 
X 
X 
 
X 
 
X 
 
X 
Dispense study medication 
kitf 
 
X 
X 
X 
 
X 
 
X 
 
 
Dispense/review diary 
 
X 
X 
X 
 
X 
 
X 
 
X 
Weigh study medication 
 
X 
X 
X 
 
X 
 
X 
 
X 
Adverse event assessmentg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
a Limited physical examination: skin, lungs, and heart only 
b  Height will be collected at Day 1 only. Weight will be collected at all study visits. Subject to void prior to weight 
being taken. Remove any jackets, outerwear and shoes. Remove any objects of significant weight (i.e. cell 
phones, wallet, key chains). A 5% weight loss should be reported to the medical monitor. 
c   IGA will be a 5-point scale ranging from clear (0) to severe (4). IGA should be completed prior to other 
physician assessments. Total BSA affected by psoriasis will be determined at each visit. A body diagram should 
be used to record areas of psoriasis involvement. 
d A urine pregnancy test will be administered to all females of child-bearing potential. A negative result is required 
for continued participation in the study, and results must be available prior to dispensing of study drug at each 
visit. 
e Local tolerability will be assessed by the clinic using the method of Berger and Bowman.   
f Kits will be dispensed based on %BSA affected. See IP Handling Manual for details.   


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g Any emergent AEs will be followed in the clinic for up to one month at the Investigator’s discretion until 
resolved or otherwise judged as clinically stable. 
h  For Cohort 1, this data will be obtained from Week 12 of ARQ-151-201 Study and used as the Day 1 data for this 
long-term safety study (ARQ-151-202). If after ARQ-151-201 completion, subjects should complete the 
screening visit procedures. The Baseline values for Safety tabulations will be taken from the day that the subject 
received their first active study drug (across studies ARQ-151-201 and ARQ-151-202). Baseline  values for 
efficacy will be those recorded on Day 1 of Study ARQ-151-201. For Cohort 2, Baseline evaluations will be 
obtained for all procedures and the Baseline/Screening version of the C-SSRS will be utilized at Screening.  For 
Cohort 2, labs that are collected within 14 days of Baseline do not need to be repeated.  
i  For Cohort 1, the consent will be signed after completion of Week 12 in ARQ-151-201. Cohort 2 will sign 
consent prior to any study-related procedures at the Screening Visit.  
 
 






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7 
BACKGROUND AND RATIONALE 
7.1 
Introduction 
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated 
with chronic bronchitis.  Roflumilast and its active metabolite, roflumilast N-oxide, are high 
affinity selective inhibitors of PDE-4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic 
AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular cyclic AMP.  
There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and PDE-4d, each with 
several isoforms (splicing variants).  IC50 values of both roflumilast and roflumilast N-oxide for 
the different PDE-4 isoforms and subtypes are mostly sub-nanomolar and single digit nanomolar 
(Hatzelmann 2010).  The PDE-4 family of enzymes are the most prevalent phosphodiesterases in 
immune cells and inhibition of PDE-4 subtypes has been associated with anti-inflammatory 
effects in many biological systems. 
 
Psoriasis is a chronic inflammatory skin disease characterized by raised, well-demarcated, 
erythematous oval plaques with adherent silvery scales.  Numerous past reports have suggested a 
deficiency of cyclic AMP-dependent protein kinases in human psoriatic skin (Brion 1986).  More 
recently, various cytokines produced by Th1 and Th17 cells have been shown to play a crucial 
role in the pathogenesis of psoriasis.  It has been postulated that the anti-inflammatory effects of 
PDE-4 inhibitors may provide a beneficial therapeutic intervention in the treatment of chronic 
plaque psoriasis and recently Otezla® (apremilast), a PDE-4 inhibitor, has been approved for the 
oral treatment of chronic plaque psoriasis. 
 
The past 15 years have witnessed a transformation in the systemic treatment of moderate to 
severe psoriasis with the advent of biological therapies.  However, for patients with milder forms 
of disease, best treated with topical options, the therapeutic landscape really has not changed in 
several decades.  Topical steroids come in all shapes and forms, but the lower potency steroids 
are not effective and the higher potency steroids are beset with issues of local skin atrophy and 
the potential for hypothalamic-pituitary axis suppression when applied over larger body surface 
areas and for prolonged periods of time.  Vitamin D has been the other staple of topical psoriasis 
treatment but it is irritating, not suitable for use on the face or intertriginous areas, and its 
efficacy is rather modest.  Hence, there is substantial medical need for additional topical 
approaches in the treatment of psoriasis. The study sponsor is developing a topical formulation 
of roflumilast for the treatment of chronic plaque psoriasis.  Our Phase 2a results suggest that 
ARQ-151 may be a highly efficacious and well-tolerated topical treatment for psoriasis. 
7.2 
Preclinical Studies  
Roflumilast was initially developed as a 500 g tablet for oral therapy in patients with COPD, 
and as such has been thoroughly evaluated in nonclinical studies.  The safety profile is well-
established and the results of those studies are relevant to the dermal roflumilast (ARQ-151 
cream) development program.  Oral roflumilast (500 g tablet) was approved by Health Canada 
as DAXAS® in December 2010 and by the US FDA as DALIRESP® in February 2011 for the 
treatment of COPD.  The study sponsor is conducting nonclinical studies in which roflumilast is 
applied dermally to supplement the information available through the registration and labeling of 




















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8.2 
Study Endpoints 
8.2.1 Primary Endpoint 
 
The primary endpoint will be analysis of safety monitored through application site assessments 
in  the clinic using the method of Berger and Bowman, clinical laboratory testing, 12-lead ECGs, 
PHQ-8, C-SSRS and adverse events.  Two primary endpoint analyses are planned: 
 
 Occurrence of Treatment Emergent Adverse Events  
 Occurrence of Serious Adverse Events  
8.2.2 Secondary Endpoints 
 
The secondary endpoints are related to efficacy and will include: 
 
 Proportion (%) of subjects achieving an Investigator Global Assessment (IGA) of clear or 
almost clear, as observed at Week 12 and subsequent scheduled visits.  
 In subjects who achieve 'clear' scores for IGA, I-IGA (if applicable and mPASI 
(Modified Psoriasis Area Severity Index) and stop treatment to all lesions, time to re-
starting study drug (duration of response). 
 Proportion (%) of applicable subjects with intertriginous area involvement, ‘I-IGA’ score 
of ‘clear’ or ‘almost clear’ at week 12 and subsequent visits 
 Proportion (%) of subjects achieving a 75% reduction from Baseline of Modified 
Psoriasis Area Severity Index-75 (mPASI-75) at weeks 12, 24, 36 and 52 as compared to 
Baseline. 
9 
INVESTIGATIONAL PLAN 
9.1 
Overall Study Design and Plan 
This is an open-label, long-term safety study of ARQ-151 cream 0.3% in subjects with chronic 
plaque psoriasis involving between 0 and 25% BSA. Eligible subjects will enroll into the long-
term safety study on the same day as the Week 12 visit for the previous study (ARQ-151-201) 
for Cohort 1 and on Day 1 for non ARQ-151-201 subjects in Cohort 2. Study medication will be 
applied by the subjects topically QD for 52 weeks at home.  
 
A total of up to approximately 300 subjects (Cohort 1) and up to approximately 100 non ARQ-
151-201 subjects (Cohort 2) will be enrolled at approximately 30 study sites in the United States 
and Canada.  Subjects will be adult (≥18 y/o) males or females with chronic plaque psoriasis. 
Periodic clinic visits will include assessments for clinical safety, application site reactions 
evaluated in the clinic using the method of Berger and Bowman, disease improvement or 
progression, and IGA.   
 
 


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9.2 
Subject Participation 
Subject participation involves a minimum of five clinic visits at Week 4, Week 12, Week 24, 
Week 36 and Week 52 of treatment. There will be three phone visits conducted at Weeks 18, 30 
and 44. The Day 1 visit of this study will be Week 12 of the ARQ-151-201 study (Cohort 1) and 
Day 1 for Cohort 2. The Baseline values for Safety tabulations will be taken from the day that 
the subject received their first active study drug. Baseline values for efficacy will be those 
recorded on Day 1 of Study ARQ-151-201. The anticipated maximum duration of subject 
participation is about 52 weeks. Subjects in the ARQ-151-201 study that choose to participate in 
the long-term extension study will transition directly into the ARQ-151-202 study at the Day 1 
visit (Week 12 of Study ARQ-151-201). 
9.3 
Randomization 
This is an open-label study and all subjects will be treated with ARQ-151 cream 0.3% QD to 
psoriatic plaques up to a maximum application area of 25% BSA.    
9.4 
Numbering of Subjects 
All screened subjects enrolled will retain their unique five-digit subject ID number previously 
assigned during the ARQ-151-201 study (Cohort 1). For Cohort 2 subjects will be numbered 
with the 2 digit site number and a three digit subject number starting with 500.    
 
The clinical site is responsible for maintaining a current log of subject ID number assignments 
and study drug kits assigned to that subject.  The subject ID number is required to be entered on 
all clinical study documentation (e.g., case report forms, labeling of clinical materials and sample 
containers, investigational product accountability logs, etc.).  
9.5 
Blinding 
This is an open-label study and no blinding is planned. 
9.6 
Selection of Patient Population 
9.6.1 Inclusion Criteria 
All Subjects  
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the 
study: 
1. Participants legally competent to sign and give informed consent 
2. Males and females ages 18 years and older  
3. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all 
study visits. In addition, sexually active FOCBP must agree to use at least one form of highly 
effective contraception throughout the trial.  Highly effective forms of contraception include: 
oral/implant/injectable/transdermal contraceptives, intrauterine device, and partner’s 
vasectomy.  If barrier methods are used (e.g., condom with spermicide, diaphragm with 




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9. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, 
nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin 
during the study period.  
10. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within the past 4 weeks.  
11. Known or suspected:  
 severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B 
or C) 
 hypersensitivity to component(s) of the investigational products  
 history of severe depression, suicidal ideation 
12. Females who are pregnant, wishing to become pregnant during the study, or are breast-
feeding. 
13. Subjects with any serious medical condition or laboratory abnormality that would prevent 
study participation or place the subject at significant risk, as determined by the Investigator. 
14. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of 
study medication. 
15. History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or 
anaphylactoid reaction) to PDE-4 inhibitors. 
16. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell 
carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. 
17. Subjects who are unable to communicate, read or understand the local language, or who 
display another condition, which in the Investigator’s opinion, makes them unsuitable for 
clinical study participation. 
Cohort 1 Only 
18. Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that 
precluded further treatment with ARQ-151 cream in Study ARQ-151-201. 
Cohort 2 Only 
19. Subjects who cannot discontinue medication and treatments  prior to the Day 1 visit 
Excluded Medications and Treatments (Table 2). 
9.6.3 Removal of Subjects from the Study 
Subject participation in this trial may be discontinued for any of the following reasons: 
1. Occurrence of any medical condition or circumstance that, in the opinion of the Investigator, 
exposes the subject to substantial risk and/or does not allow the subject to adhere to the 
requirements of the Protocol. 
2. Occurrence of a treatment-emergent adverse event (TEAE) or considerable worsening of an 
AE that, in the opinion of the investigator in consultation with the Medical Monitor and 


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Sponsor, represents an unacceptable risk to the subject if he/she continues in the study.  The 
investigator must follow the subject until the AE resolves or satisfactorily stabilizes. 
3. Pregnancy. 
4. Subject's decision to withdraw. 
5. Weight loss of >5% if not dieting or intentionally trying to lose weight and after consultation 
with the Sponsor, at the Investigator’s discretion. 
6. C-SSRS indicative of suicidal ideation or a PHQ-8 score ≥15, after consultation with a 
mental health professional, the Sponsor, and at the Investigator’s discretion. 
7. Requirement for use of prohibited concomitant medication. 
8. Subject’s repeated failure to comply with protocol requirements or study related procedures. 
9. Termination of the study by the Sponsor, FDA, or other regulatory authorities. 
9.7 
Study Restrictions 
9.7.1 Prohibitions and Concomitant Therapy 
Prohibited medications and products are detailed in Table 1 (Excluded Medications and 
Treatments).   
Generally, the addition of new medications, including nonprescription medications, during the 
course of the study is discouraged.  However, it is recognized that this is a 52-week study and 
subjects may be required to start chronic medications for health benefits.  The use of such 
chronic medications may be authorized by the Investigator.  The Investigator must make the 
decision to authorize the use of any such medication only after consideration of the clinical 
situation, the potential for masking symptoms of a more significant underlying event, and 
whether the use of the medication will compromise the outcome or validity of the clinical 
investigation.  Short-term medications, such as antibiotics to treat acute infections, are allowed.  
If medication is required, the name, strength, frequency, duration of use, and reason for use will 
be recorded in source documents and transcribed to Case Report Forms.  Medications which 
have already been used chronically by subjects, in particular statins and anti-hypertensives, are 
allowed for use during the study.   
 
 


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Table 1.  Excluded Medications and Treatments 
Excluded Medications and Treatments 
Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris  
Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (eg, oral 
corticosteroids, retinoids, apremilast, methotrexate, cyclosporine and other systemic 
immunosuppressants 
Topical anti-psoriasis medications (e.g., corticosteroids, vitamin D analogs, prescription shampoos) 
(except for emollients) 
PUVA phototherapy 
UVB  
Investigational drugs (except ARQ-151 cream) 
Note:   
Eye drop and nasal corticosteroid preparations are allowed.   
 
Inhaled corticosteroid preparations are allowed if used for a stable condition and at a stable 
dose for > 28 days before Day 1, and are continued at the same dose throughout the study. 
 
Non-medicated emollients, moisturizers and sunscreens will be allowed as used normally 
by the subjects. These can be applied to non-treated areas as needed. Study medication 
should be applied at least 20 minutes before going to bed and no other emollients or 
moisturizers should be applied to the treated area.   
 
A tar-containing or a dandruff shampoo (zinc pyrithione or selenium sulfide) shampoo is 
allowed for treatment of the scalp. 
 
Table 2.  Wash Out Period for Medications and Treatments (Cohort 2) 
 
Excluded Medications and Treatments 
Wash Out Period Prior to Day 1 
 Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within the 
following time periods prior to enrollment: 
Etanercept 
4 weeks 
Adalimumab, infliximab 
8 weeks 
All other biologics 
12 weeks 
 All other therapies with a possible effect on psoriasis vulgaris: 
Oral corticosteroids, retinoids, apremilast, methotrexate, 
cyclosporine and other systemic immunosuppressants 
4 weeks 
Topical anti-psoriasis medications (e.g., topical 
corticosteroids, vitamin D analogs, prescription shampoos) 
(except for emollients) 
2 weeks 
PUVA phototherapy 
4 weeks 
UVB  
2 weeks  
Systemic retinoids 
12 weeks 
Investigational drugs 
12 weeks (biologics); 
5 half-lives (orals);  
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9.8 
Investigational Product and Treatment 
9.8.1 Drug Supplies, Packaging and Labeling 
ARQ-151 cream 0.3% will be provided in 45 gram squeeze tubes.  The tubes will be packaged in 
kits, each containing 8 tubes of investigational product. The number of kits dispensed to a 
subject will be based on the BSA involvement of psoriasis.  It is anticipated that the maximum 
number of kits dispensed to a subject will be ten. The kits and tubes will be labeled including a 
location to record the subject ID on the label. 
 
The Sponsor will supply sufficient quantities of the study drug (ARQ-151 cream 0.3%,) to each 
site to allow for completion of this study. 
 
Records will be made of the receipt and dispensing of the study drugs supplied. At the 
conclusion of the study, any unused study drugs will be returned to the Sponsor or designee, or 
destroyed, as per Sponsor instructions. 
9.8.2 Treatment Administration 
At the Day 1 visit, subjects will be instructed to apply study medication once daily.  All subjects 
should apply medication each evening at least 15 minutes after showering or bathing (if they take 
an evening shower/bath) and then not wash areas where ARQ-151 cream has been applied until 
the following morning. Study medication should be applied at least 20 minutes before going to 
bed.  
 
Subjects should continue to apply study medication to all active psoriasis lesions including any 
new plaques that develop during the study.  A Body Diagram should be used to record existing 
and new areas of psoriasis involvement that are subject to treatment. 
 
Psoriasis plaques that have completely resolved, in the opinion of the investigator, do not require 
continued treatment. If psoriasis plaques appear to resolve at some time between study visits, 
study medication should continue to be applied until the next scheduled visit.  At that visit, the 
Investigator will perform an assessment and determine whether or not to discontinue treatment. 
Study medication will be weighed prior to dispensing at all visits where study medication is 
dispensed.. Study medication, both empty and full tubes, must be returned by subjects at each 
study visit and will be weighed.  
9.8.3 Treatment Compliance  
Study medication tubes will be weighed at each follow-up clinic visit.   
Subjects will complete a daily diary recording the date and time of each dose applied, any missed 
doses, and a comment section should the subjects have a comment, e.g., record potential AEs. 
Site personnel will review the diaries and use the information to question the subject regarding 
compliance and AEs and then record appropriate information in source documents and complete 
Case Report Forms (CRFs).  If a subject misses a dose, they should be instructed to return to the 


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protocol study medication administration schedule (i.e. if subject forgets a dose they should wait 
until that evening and apply as usual).   
Compliance will be assessed by review of the dosing diary. Weight of study medication applied 
will be measured for reporting purposes. Compliance will be documented in source and in eCRF. 
10 STUDY PROCEDURES  
10.1 Safety Assessments 
The Schedule of Visits and Assessments (see Section 5) summarizes the clinical procedures to be 
performed at each visit. Individual clinical procedures are described in detail below. Additional 
evaluations/testing may be deemed necessary by the PI and/or the Sponsor for reasons related to 
subject safety. 
This study assesses the long-term safety of ARQ-151 cream 0.3%. Safety will be monitored 
through application site assessments in  the clinic using the method of Berger and Bowman, 
physical examination, clinical laboratory testing, 12-lead ECGs, PHQ-8, C-SSRS and AEs as 
outlined in the Schedule of Visits and Assessments (Section 5). If deemed necessary, additional 
safety assessments will be performed at the discretion of the Investigator. 
Screening Visit (Cohort 2) 
Within 35 days prior to the first dosing, non ARQ-151-201 subjects will be provided details of 
study requirements and sign an informed consent.  Each subject will undergo psoriatic plaque 
assessments, a physical examination, vital sign measurements (blood pressure, heart rate, and 
temperature), PHQ-8, C-SSRS, and laboratory tests: hematology, chemistry, urinalysis and a 
pregnancy test for female subjects of child bearing potential. 
Screening should occur for Cohort 1 subjects if they have completed ARQ-151-201 previously. 
All screened subjects will receive a screening number and be entered into the electronic subject 
tracking system. 
Day 1 Visit 
At Day 1 (Week 12 of the ARQ-151-201 study or Day 1 for non ARQ-151-201) ARQ-151-201 
subjects will be provided details of study requirements and sign an informed consent.  Medical 
history and demographic data, psoriatic plaque assessments (IGA, I-IGA, mPASI and BSA), 
physical examination, vital sign measurements (blood pressure, heart rate, and temperature), 
PHQ-8, C-SSRS, laboratory tests: hematology, chemistry, urinalysis and a pregnancy test for 
female subjects of child bearing potential will be obtained at Week 12 visit of study ARQ-151-
201 and will serve as the Day 1 for ARQ-151-201 subjects (Cohort 1). Cohort 2 Day 1 
assessments for this long-term safety study (ARQ-151-202) will be completed within 35 days of 
Screening. The Baseline values for Safety tabulations will be taken from the day that the subject 
received their first active study drug (across studies ARQ-151-201 and ARQ-151-202). Baseline 
values for efficacy will be those recorded on Day 1 of Study ARQ-151-201 (Cohort 1) and Day 1 
of ARQ-151-202 for non ARQ-151-201 subjects (Cohort 2). 


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Cohort 2 subjects must meet the required wash out period for any excluded medications and 
treatments according to Table 2.  
All Cohort 1 subjects will retain their Subject ID from the previous study which will be entered 
into the electronic subject tracking system for this long-term safety study. Cohort 2 subject study 
numbers will include the 2 digit site number and the three digit subject number will begin with 
500. 
Scheduled Visits (Day 1 and Visits 1 – 5) 
10.1.1 Physical Examination 
 
Physical examinations will be performed as follows: 
 
Day 1, Week 24, and Week 52.   
The physical exam will be limited to skin, lungs and heart only. 
10.1.2 Vital Signs, Height and Weight 
 
Vital signs will be collected at timepoints noted below: 
 
Blood pressure, heart rate, and temperature will be measured at all study visits.  
 
Height will be collected at Day 1 only.  
 
Weight will be collected at all study visits. Subject to void prior to weight being taken and 
remove any jackets, outerwear and shoes. Remove any objects of significant weight (i.e. cell 
phones, wallet, key chains). A 5% weight loss should be reported to the medical monitor. 
10.1.3 12-lead ECGs 
 
12-lead ECGs will be performed as follows: 
 
Day 1, Week 24 and Week 52. 
 
ECGs will be performed on subjects after 5 minutes in the supine position. All ECG tracings and 
readouts will be reviewed by the central reader at the ECG laboratory. 
10.1.4 Laboratory Tests 
All tests listed below will be performed as follows: 
Day 1, Weeks 4, 12, 24, 36, 52.    
 
 


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All tests listed below will be performed according to the Study Events Flow Chart unless 
otherwise noted. The collection of specimens will be in a non-fasting state. In addition, 
laboratory safety tests may be performed at various unscheduled timepoints, if deemed necessary 
by the Investigator. 
Hematology 
 
Serum Chemistry 
 Hemoglobin 
 Hematocrit  
 Total and differential leukocyte count 
 Red blood cell count with indices and 
morphology 
 Platelet count 
 
 Blood Urea Nitrogen 
 Bilirubin (total and direct) 
 Alkaline phosphatase 
 Aspartate aminotransferase 
 Alanine aminotransferase 
 Albumin 
 Sodium 
 Potassium 
 Chloride 
 Glucose 
 Creatinine  
Urinalysis 
 
Additional Tests 
 pH 
 Specific gravity 
 Protein* 
 Glucose 
 Ketones 
 Bilirubin 
 Blood* 
 Nitrite* 
 Urobilinogen 
 Leukocyte esterase* 
 
 Urine pregnancy test** 
(for females of child bearing potential 
only) 
* If urinalysis is positive for protein, blood, nitrite and/or leukocyte esterase, a microscopic examination (for red blood 
cells, white blood cells, bacteria, casts, and epithelial cells) will be performed. 
** At Day 1, Weeks 4, 12, 24, 36 and 52 for FOCBP only  
10.1.5 Patient Health Questionnaire depression scale (PHQ-8)  
 
The 8 item PHQ-8 Assessment will be performed as follows: 
 
Day 1, Weeks 4, 12, 24, 36, and 52 
 
Subjects will complete PHQ-8 questionnaire. 
 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and, if currently applying study drug, consideration be given to discontinuation 
from study drug.   
 


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The PHQ-8 
 
 
PHQ-8 score is the sum of the responses for the 8 questions. 
 
Five severity categories of depression are defined as follows:  
 None – Minimal depression (0 to 4)  
 Mild depression (5 to 9)  
 Moderate depression (10 to 14)  
 Moderately severe depression (15 to 19)  
 Severe depression (20 to 24) 
10.1.6 Columbia-Suicide Severity Rating Scale (C-SSRS)  
 
C-SSRS Assessments will be performed as follows: 
 
Day 1, Weeks 4, 12, 24, 36, and 52 
 
On all visits, the Since Last Visit version (Appendix 1) will be used for Cohort 1. 


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Cohort 2 will use the Baseline/Screening version (Appendix 2) for Day 1 and Since Last Visit 
version for all remaining visits.  
 
 
Any score greater than 0 in the suicidal ideation score is important and may indicate the 
need for mental health intervention and consideration be given to discontinuation from 
study drug. This should result in prompt referral to a mental health professional and/or 
possibly the emergency room. The Medical Monitor should be contacted.  
 
Clinical study staff that administer the C-SSRS will be trained via the C-SSRS training video. A 
training certificate for the administer(s) will be on file in the trial master file at the site. 
 
The Investigator must review the completed C-SSRS.  A qualified mental health care provider 
must be available, immediately if needed, to refer the subject for further evaluation. 
10.1.7 Local Tolerability Assessments  
The Investigator Local Tolerability Assessment will be performed as follows: 
Day 1, Weeks 4, 12, 24, 36, and 52 
Application site reactions will be graded at the timepoints outlined in the Schedule of Visits and 
Assessments (Section 5).  Irritation reactions are graded using the scale detailed in the following 
section (Berger-1982).  Reactions at the site of product application, which may occur post-Day 1 
visit, should be differentiated from the preexisting inflammation associated with the subject’s 
psoriasis.   
 
Dermal Response 
0 = no evidence of irritation 
1 = minimal erythema, barely perceptible 
2 = definite erythema, readily visible; minimal edema or minimal papular response 
3 = erythema and papules 
4 = definite edema 
5 = erythema, edema and papules 
6 = vesicular eruption 
7 = strong reaction spreading beyond application site 
 
 


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Other Effects 
 
A = slight glazed appearance 
 
B = marked glazing 
 
C = glazing with peeling and cracking 
 
D = glazing with fissures 
 
E = film of dried serous exudates  
 
F = small petechial erosions and/or scabs 
G = no other effects 
 
10.1.8 Adverse Events  
 
Adverse events (AEs) will be collected beginning at informed consent and assessed as follows: 
Day 1, Weeks 4, 12, 24, 36, and 52 
Any treatment emergent AEs will be followed in the clinic for up to one month at the 
Investigator’s discretion until resolved or otherwise judged as clinically stable.  
A psoriasis flare will be considered an AE in this study. For further details on Adverse Events 
please see Section 10.6. 
 
10.1.9 Phone Visits 
 
Phone visits -- Weeks 18, 30 and 44 -- will be conducted for all subjects to review any adverse 
event or concomitant medication changes. 
 
Subjects will call the site when psoriasis returns prior to restarting application of study drug.  
10.2 Efficacy Evaluations  
10.2.1 Investigator’s Global Assessment (IGA) 
 
Investigator’s Global Assessments (‘whole body’) will be performed at the following study 
visits. The IGA should be completed prior to other physician assessments. 
 
Day 1, Weeks 4, 12, 24, 36, and 52 
 
The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment 
scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade 
is defined by a distinct and clinically relevant morphologic description that minimizes inter-
observer variability.  
 
Unlike the Phase 2b study, an Intertriginous-IGA will not be done in this open-label extension 
study.  However, study medication should be applied to intertriginous areas if affected. 
 




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For subjects with intertriginous area involvement of at least ‘mild’ severity by IGA (I-IGA≥2) at 
Day 1 (using the IGA scale shown above but evaluating intertriginous areas ONLY and NOT 
whole body involvement), an IGA for the intertriginous region alone (I-IGA) will be recorded at 
weeks 4, 12, 24, 36 and 52.   
This ‘intertriginous area IGA’ (I-IGA) should be done AFTER the ‘standard whole body 
IGA’ (primary endpoint) in subjects who qualify.  
10.2.2 
Modified Psoriasis Area and Severity Index (mPASI) 
mPASI Assessments will be performed as follows: 
Screening, Baseline, Weeks 4, 12, 24, 36 and 52 
Every effort should be made for the same Evaluator to complete the mPASI for the subject 
at every study visit. 
 
Modified Psoriasis Area and Severity Index (mPASI) is used for the measurement of severity of 
psoriasis.  
 
mPASI combines the assessment of the severity of lesions and the area affected into a single 
score in the range 0 (no disease) to 72 (maximal disease). 
The body is divided into four sections (head (h) (10% of a person's skin); arms (a) (20%); trunk 
(t) (30%); legs (l) (40%)). Each of these areas is scored by itself, and then the four scores are 
combined into the final mPASI. For each section, the percent of area (A) of skin involved is 
estimated and then transformed into a grade from 0 to 6 (A): 
 
0. 0% of involved area 
1. < 10% of involved area - see below for Modified PASI (mPASI) for this grade 
2. 10–29% of involved area 
3. 30–49% of involved area 
4. 50–69% of involved area 
5. 70–89% of involved area 
6. 90–100% of involved area 
 
mPASI: for subjects with < 10% of an involved anatomic area, the mPASI will be calculated 
using the actual percentage of the anatomical area involved (e.g. 0.1 for 1%, 0.2 for 2%, 0.3 for 
3%, … 0.9 for 9%), corresponding to the actual percentage of that particular anatomical area of 
involvement.  
 
Note: Palms and soles may be treated with study medication in this study, but will not be 
counted towards IGA, mPASI, or BSA assessments. 
 
Within each area, the severity is estimated by three clinical signs: erythema (‘E’; redness), 
induration (‘T’; thickness) and desquamation (‘S’; scaling). Severity parameters are measured on 
a scale of 0 to 4, from none to maximum severity possible. 


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To calculate the mPASI, the sum of the severity rating for the three main signs are multiplied 
with the numerical value of the area affected and with the various percentages of the four body 
areas. These values are then added to complete the formula as follows: 
 
PASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 
0.4 (El + Tl + Sl) Al 
10.2.3 Body Surface Area (BSA) 
BSA Assessments will be performed as follows: 
Day 1, Weeks 4, 12, 24, 36, and 52 
The BSA affected by psoriasis will be determined by the subject’s hand method, where the 
subject’s hand (including fingers) surface area is assumed to equal 1% of body surface area 
(BSA).   
 
Note: Palms and soles will be treated with study medication, but will not be counted towards 
IGA or BSA assessments. The scalp is not treated and will not be counted towards any 
assessments. 
10.3 Final Study Visit – End of Study 
The final study visit will occur approximately at the end of week 52 of overall involvement in 
the study. The procedures performed during this visit are as described in Section 10.1 and 
Section 10.2 and the Schedule of Events for the Week 52 visit (Section 5). A 7 day scheduling 
leeway period is allowed for this visit. In addition to the listed procedures to be performed, 
adverse events will be recorded as reported by the participant or as observed and followed to 
resolution as necessary (see Section 10.1.8). 
10.4 Early Termination Visit 
If a subject is withdrawn or wishes to exit the study, a termination visit will be scheduled. This 
visit should include the procedures and assessments that would be performed at the final study 
visit (End of Study visit; see Section 10.3). 
10.5 Unscheduled Visit 
Subjects that clear between scheduled visits should return for an unscheduled visit for the 
investigator to confirm IGA, I-IGA (if applicable) and mPASI are clear and subject may stop 
application of study drug. Unscheduled visits may be necessary for the purpose of measuring 
time to restarting study drug for those subjects that stopped application of study medication due 
to resolution of psoriasis plaques. Subjects will call the site when psoriasis returns prior to 
restarting application of study drug. Unscheduled visits also may be necessary to repeat testing 
following abnormal laboratory results, for follow-up of AEs, or for any other reason, as 
warranted in the judgement of the Investigator. 
 
 
 


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The following information will be collected for all subjects: 
 Concomitant medications/procedures 
 AEs 
 
The following information will be collected for those subjects that had stopped study medication 
but are experiencing a reoccurrence of psoriasis plaques: 
 Time between stopping study medication and restarting application 
 Investigator’s Global Assessment (IGA) of psoriasis severity 
 Body Surface Area (BSA) of psoriasis involvement (not palms, soles, or scalp) 
 
An updated Body Diagram of psoriasis involvement should be provided to the subject. 
 
The rules for how to tally IGA or other proportions of categorical responses will be described in 
the Statistical Analysis Plan. 
10.6 Adverse Events 
10.6.1 Adverse Event Definition 
An AE means any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered drug related. An AE can therefore be any unfavorable and unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product.  
AEs will be collected following informed consent of the subject through subject study 
completion.  
A treatment emergent adverse event (TEAE) is defined as an AE that started post application of 
study medication through study completion.  
Application site reactions will be considered adverse events if they require intervention, 
suspension or discontinuation of study drug.  
10.6.2 Serious Adverse Event 
The definitions and reporting requirements of Health Canada/the Food and Drug Administration 
(FDA)/ICH Guidelines for Clinical Safety Data Management, Definitions and Standards for 
Expedited Reporting, Topic E2A will be adhered to. If any AEs are serious, as defined by ICH 
Guidelines for Clinical Safety, required procedures will be followed. All SAEs will be reported 
to the Sponsor via fax or e-mail within 24 hours of becoming aware of the event, whether or not 
the serious events are deemed drug-related. All serious event reporting will adhere to ICH E6: 
Guideline for Good Clinical Practice and ICH E2A: Clinical Safety Data Management: 
Definitions and Standards for Expedited Reporting.:  The ERB/IRB will be notified of the Alert 
Reports as per HC, FDA, ICH and the IRB/ERB’s policies and procedures. 


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An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following 
outcomes:  Death, a life-threatening AE, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, or a congenital anomaly/birth defect.  Important medical events 
that may not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based upon appropriate medical judgment, they may jeopardize the subject and 
may require medical or surgical intervention to prevent one of the outcomes listed in the above 
definition. Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse.  
Life-threatening is defined as an AE that in the view of the PI or Sponsor, places the subject at 
immediate risk of death. It does not include an AE that, had it occurred in a more severe form, 
might have caused death. 
Hospitalization does not include the following: 
 Rehabilitation facilities, hospice facilities or respite care (e.g. caregiver relief) 
 Nursing homes or skilled nursing facilities 
 Emergency room visits 
 Same day surgeries (as outpatient/same day/ambulatory procedures) 
 <24 hour admissions for observation or evaluation 
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical AE is 
not in itself an SAE.  Examples include: 
 Admission for treatment of a preexisting condition that did not worsen 
 Hospitalizations for cosmetic elective surgery, social, and/or convenience admissions 
 Pre-planned treatments or surgical procedures should be noted in the history 
documentation for the individual subject. 
 Diagnostic and therapeutic procedures, such as surgery, should not be reported as AEs; 
however, the medical condition for which the procedure was performed should be 
reported if it occurs during the reporting period and meets the definition of an AE.  For 
example, an acute appendicitis that begins during the AE reporting period should be 
reported as an AE, and the resulting appendectomy should be recorded as treatment of the 
AE. 
Unexpected is defined as an AE that is not listed in the IB or is not listed at the specificity or 
severity that has been observed; or is not consistent with the risk information described in the 
general investigational plan or elsewhere in the current IND/CTA. 
If a SAE occurs to a subject on this study, contact the Sponsor personnel listed in Section 2 
within one business day of knowledge of event.  


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10.6.3 Suspected Unexpected Serious Adverse Reaction (SUSAR)  
This is defined as a serious adverse reaction, the nature or severity of which is not consistent 
with the known study treatment information. A serious event or reaction is not defined as a 
SUSAR when: ‘it is serious but expected’ or it does not fit the definition of an SAE, whether 
expected or not.  
10.6.4 Safety Review 
At each follow-up visit, subjects will be queried with an open-ended question such as: ‘How 
have you been feeling since your last visit?’  Additionally, the study staff will review subject 
diaries and, if it appears that a potential AE was recorded, study staff will query the subject and 
determine if an AE occurred.   
AEs (whether serious or non-serious) and clinically significant abnormal laboratory test value(s) 
will be evaluated by the PI and treated and/or followed up for up to one month after end of 
treatment until the symptoms or value(s) return to normal, or acceptable levels, as judged by the 
PI. 
Where appropriate, medical test(s) and/or examination(s) will be performed to document 
resolution of event(s). Outcome may be classified as resolved, improved, unchanged, worse, fatal 
or unknown (lost to follow-up). 
10.6.5 Adverse Event Reporting 
The PI will review each event and assess its relationship to drug treatment (unrelated, unlikely, 
possibly, probably, likely). Each sign or symptom reported will be graded on the NIH NCI 
CTCAE toxicity grading scale 5-point severity scale (Grade 1, 2, 3, 4 and 5). The date and time 
of onset, time relationship to drug dosing, duration, and outcome (resolved, improved, 
unchanged, worse, fatal, or unknown/lost to follow-up) of each event will be noted. 
The relationship of each AE to the study drug will be assessed using the following definitions: 
Unrelated 
 
The AE must clearly be caused by the subject’s clinical state, or the study 
procedure/conditions. 
 
Definitely not related to drug. 
 
Temporal sequence of AE onset relative to administration of drug not reasonable. 
 
Another obvious cause of an AE. 
Unlikely 
 
Time sequence is unreasonable. 
 
There is another more likely cause for an AE. 
Possibly 
 
Corresponds to what is known about the drug. 
 
Time sequence is reasonable. 
 
Could have been due to another equally, likely cause. 
Probably 
 
Is a known effect of the drug. 
 
Time sequence from taking drug is reasonable. 
 
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 
Cannot be reasonably explained by the known characteristics of the subject’s 
clinical state. 
Likely 
 
Is a known effect of the drug (e.g., listed in Physicians' Desk Reference, 
Compendium of Pharmaceuticals and Specialties, IB). 
 
Time sequence from taking drug is reasonable. 
 
Event stops upon stopping drug, event returns upon restarting drug. 
The following CTCAE toxicity grading scale 5-point severity scale definitions for rating 
maximum severity will be used: 
 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
Grade 2 
Moderate; minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living.* 
Grade 3 
Severe or medically significant but not immediately life-threatening; 
Hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care activities of daily living.** 
Note: An experience may be severe but may not be serious, e.g., severe 
headache). 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE. 
Note:  A semi-colon indicates ‘or’ within the description of the grade. 
*Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the telephone, 
managing money, etc. 
**Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, 
and not bedridden. 
AEs will be coded using the most current MedDRA® version available at the start of the study 
(e.g., 21.0 or higher). 
10.7 Reporting Pregnancy  
During the study, all subjects should be instructed to contact the investigator immediately if they 
suspect they might be pregnant (e.g., missed or late menstrual period).  If pregnancy is 
confirmed, the subject will be withdrawn from the study and followed until the pregnancy comes 
to term.   
The investigator is responsible for reporting all available pregnancy information on the 
pregnancy report within 24 hours of becoming aware of the event, although pregnancy itself is 
not considered an AE.  Study treatment must be discontinued immediately in the event of a 
pregnancy.  The subject should be referred to an obstetrician/gynecologist experienced in 
reproductive toxicity for further evaluation and counseling. Monitoring of the subject should 
continue until the conclusion of the pregnancy.  Follow-up information detailing the outcome of 
the pregnancy and the health of the newborn should be reported as it becomes available.   
Partner pregnancies of a male subject do not need to be reported. 


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Any pregnancy complication or premature terminations including miscarriage, spontaneous 
abortion or elective termination of a pregnancy for medical reasons will be reported as an SAE, 
as described in Section 10.6.2. Should the pregnancy result in a congenital abnormality or birth 
defect, a separate SAE report must be submitted.  Furthermore, all neonatal deaths that occur 
within 30 days of the birth should be reported as SAEs, without regard to causality.  In addition, 
any infant death that occurs after the 30-day reporting period that the investigator suspects is 
related to the in-utero exposure to the study treatment should also be reported.  
10.8 Treatment Stopping Rules 
For subjects that clear (i.e. have an IGA score of 0 (Clear), an I-IGA (if applicable) of 0 (Clear) 
and an mPASI of 0) treatment may be stopped.  The subject will be instructed to document in 
their diary when they resume treatment with study drug if psoriasis returns. If the subject clears 
between study visits they should be scheduled for an unscheduled visit for the Investigator to 
confirm the subject has cleared.  
 
Subjects will call the site when psoriasis returns prior to restarting application of study drug.  
 
If a subject has non-cutaneous adverse events of concern, clinically significant laboratory values 
or any condition that the investigator determines could possibly be related to the study drug, 
the Investigator should immediately contact the Medical Monitor to discuss if the subject should 
be discontinued from the study.   
 
Treatment for any individual subject will be discontinued if the subject experiences:  
 
A serious adverse event (SAE) or a clinically significant non-serious AE which in the 
opinion of the Principal Investigator or Medical Monitor warrants discontinuation from 
the study for that subject’s well-being. 
 
A severe (Grade 3) laboratory abnormality (confirmed by repeat sample and considered 
related to study drug).  
o See Appendix 2 for details. 
Dosing of study drug for an individual subject may be suspended for safety concerns other than 
those described above, at the discretion of the investigator if he/she feels the subject’s safety may 
be threatened. 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and consideration be given to discontinuation from study drug.   
A subject that is experiencing suicidal ideation and behavior should be referred immediately to a 
qualified mental health care provider and consideration given to discontinuation from study drug. 
As noted above, study treatment must be discontinued immediately in the event of a female 
subject’s pregnancy.   
Treatment should be interrupted: 


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 If a subject develops an application site reaction with the clinical appearance of an 
‘irritation reaction’, and with a severity of a Dermal Response Score of 5 (erythema, 
edema and papules) or greater on the scale of Berger and Bowman. Treatment can be 
interrupted for up to one week and may then be resumed if the reaction has, in the 
opinion of the Investigator, adequately resolved.   
 
Treatment should be discontinued: 
 
If the reaction reoccurs, treatment should be discontinued permanently, and the subject 
followed until the reaction resolves.  Given the excellent local toleration in the Phase 1/2a 
study, such reactions are possible, but unlikely. 
11 DATA ANALYSIS 
Data will be handled and processed according to the Contract Research Organization’s Standard 
Operating Procedures, which are written based on the principles of GCP. 
11.1 Statistical Methods 
The methodology presented below is a summary of the more detailed analysis plan that will be 
presented in the Statistical Analysis Plan (SAP).  The SAP will be finalized before the database 
is locked and unblinded.  Any changes to the methods described in the final SAP will be 
described and justified in the clinical study report.  
All statistical processing will be performed using SAS® (Version 9.4) unless otherwise stated. 
No interim efficacy analyses are planned. 
Descriptive statistics will be used to provide an overview of the safety and efficacy results.  For 
categorical parameters, the number and percentage of subjects in each category will be 
presented. The denominator for percentage will be based on the number of subjects appropriate 
for the purpose of analysis.  For continuous parameters, descriptive statistics will include n 
(number of subjects), mean, standard deviation (SD), median, minimum, and maximum. 
Missing efficacy and/or safety data will remain missing and will not be estimated. 
11.1.1 Baseline Definition 
 
Cohort 1 baseline value for each parameter will be defined as the last observation prior to first 
dose of ARQ-151 cream 0.3% or ARQ-151 cream 0.15%.  For subjects receiving either active 
study drug in ARQ-151-201, the baseline values from ARQ-151-201 will be considered the 
baseline values for calculations in ARQ-151-202. For subjects receiving Vehicle in ARQ-151-
201, baseline values will most commonly be from the Week 12/study exit visit of ARQ-151-201. 
If subjects choose to enroll in this study, study procedures will not be repeated; study sites will 
carry over the information from the ARQ-151-201 study (Week 12 visit) to the Day 1 visit for 
this study.  Baseline values for IGA, however, will be taken from Day 1 of Study ARQ-151-201 
for all subjects. 
 
Cohort 2 baseline value for each parameter will be collected on Day 1.  


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11.1.2 Determination of Sample Size 
A sample size of approximately 300 subjects is planned for Cohort 1 and up to approximately100 
subjects in Cohort 2 is planned for the study. This sample size will provide a sufficient 
population size to evaluate the long-term safety of ARQ-151 cream 0.3% at 52 weeks. 
11.1.3 Subjects to Analyze 
All analyses will be performed using the Safety Population which includes all subjects who are 
enrolled and received at least one confirmed dose of ARQ-151 cream 0.15% or ARQ-151 cream 
0.3% study medication either in the Phase 2b Study (ARQ-151-201) or this extension study 
(ARQ-151-202). The number of patients included in the Safety Population will be summarized. 
11.1.4 Interim Analysis 
No interim efficacy analyses are planned. 
11.1.5 Background and Demographic Characteristics 
Descriptive statistics will be used to summarize demographic characteristics (age, sex, and race) 
and background characteristics for the enrolled subjects.  Past/coexistent medical history 
information and physical examination observations and vital signs information for all subjects 
will be presented in a by-subject listing.   
11.1.6 Study Medication Compliance 
The number of study drug applications by each subject based on diary data will be summarized 
using summary statistics (mean, standard deviation [SD], median, minimum, and maximum), and 
categorically.  
The amount of study medication used by each subject based on tube weight will be summarized 
using summary statistics (mean, SD, median, minimum, and maximum), and categorically.   
11.2 Safety Evaluation 
The following analyses will be performed; however, no formal inferential statistics will be done 
on safety assessments. 
Descriptive statistics will be presented by scheduled study visit for quantitative safety data and 
frequency counts will be compiled for classification of qualitative safety data. Summaries of 
local tolerability will be presented by scheduled study visit. 
11.2.1 Adverse Events 
All treatment-emergent AEs occurring during the study will be recorded and classified on the 
basis of MedDRA terminology for the safety population. Treatment-emergent AEs are those AEs 
with an onset on or after the date of study treatment. All treatment-emergent AEs will be 


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summarized by scheduled study visit, the number of subjects reporting treatment-emergent AEs, 
system organ class, preferred term, severity, relationship, and seriousness. 
Serious adverse events (SAEs) will be listed by subject. SAEs will be summarized by severity 
and relationship to study treatment. Each subject will be counted only once within a system 
organ class or a preferred term using the event with the greatest relationship and greatest 
severity. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding study drug, corrective treatment, outcome, and drug 
relatedness. The event onset will also be shown relative (in number of days) to date of first 
application. In addition, a list of subjects who prematurely discontinue from the study due to 
adverse events will also be provided. 
A subject-by-subject treatment-emergent AE (TEAE) data listing, including verbatim term, 
preferred term, treatment, severity, and relationship to study drug, will be provided.  
Medical history will be listed by subject. Physical examinations and 12-lead ECGs will be listed 
by subject. 
11.2.2 Medical History and Physical Examinations 
Medical history for all subjects will be presented in a by-subject listing.  
Physical examination findings for all subjects will be presented in a by-subject listing.  Changes 
in physical examinations will be described in the text of the final report. 
11.2.3 Clinical Laboratory Results and Vital Signs/Weight Measurements 
Vital signs will be tabulated by scheduled study visit. 
Routine blood chemistries and urinalysis will be obtained throughout the study and the results 
summarized by parameter and at scheduled study visits. 
All clinical laboratory results and vital signs measurements and their change from baseline will 
be summarized along with timepoint of collection. 
A shift table describing out-of-normal range shifts will be provided for clinical laboratory results.  
A shift table will identify subjects who gain or lose >5% body weight over the course of the 
study. 
11.2.4 ECG: 
ECGs will be tabulated by scheduled study visit. 


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11.2.5 Local Tolerance Assessments: 
For the Investigator’s assessment the numeric application site reaction scores will be summarized 
individually by using number and percentage of subjects by visit. 
11.2.6 PHQ-8 
Data will be analyzed by a shift in state of severity using the following scoring system: 
 None – Minimal depression (0 to 4) 
 Mild depression (5 to 9) 
 Moderate depression (10 to 14) 
 Moderately severe depression (15 to 19) 
 Severe depression (20 to 24) 
 
11.2.7 C-SSRS 
The C-SSRS will be analyzed per the Columbia–Suicide Severity Rating Scale Scoring and Data 
Analysis Guide. 
11.2.8 Prior and Concomitant Medications 
Prior and concomitant medication information for all subjects will be presented in a by-subject 
listing.  Summary tables will be presented by World Health Organization-Anatomical 
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product. 
11.3 Efficacy Evaluation 
This study is not intended to assess efficacy, but rather the IGA, I-IGA and mPASI are included 
to determine the need for treatment and subsequent re-treatment after treatment course in Study 
ARQ-151-201 or Study ARQ-151-202.  Certain efficacy data and endpoints will, however, be 
summarized. 
 
Descriptive statistics will be used to summarize the assessment of efficacy.  IGA scores will be 
summarized at Baseline Visit of Study ARQ-151-201 and every scheduled visit through end of 
the study (Day 1 and Weeks 4, 12, 24, 36, and 52).  The efficacy variable in this study is success 
in Investigator Global Assessment (IGA) of disease severity, defined as an IGA of ‘Clear’ or 
‘Almost Clear’.  The number and percentage of patients who achieve treatment success at the 
scheduled study visits will be tabulated. The proportion of successes for the secondary variables 
of I-IGA and 75% reduction in mPASI will be tabulated in a similar manner. 
 
The number of treatment free days until the first retreatment (relapse) will be calculated and 
analyzed. For rollover subjects previously treated with Vehicle Cream, the number of treatment 
free days will be the number of days between the end of the initial treatment in study ARQ-151-
202 and the start of the next treatment in study ARQ-151-202 if one should be needed or the end 
of the subject’s participation in study ARQ-151-202. For rollover subjects previously treated 


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with ARQ-151 cream 0.3% or ARQ-151 cream 0.15%, the number of treatment free days will be 
the number of days between the last treatment that began in Study ARQ-151-201 and the start of 
the next treatment in study ARQ-151-202 if one should be needed or the end of the subject’s 
participation in the study ARQ-151-202. There may be additional analyses comparing subjects 
that were previously treated with ARQ-151 cream 0.3% and ARQ-151 cream 0.15% in the ARQ-
151-201 study.  
 
Descriptive statistics for retreatment rates will be presented. The time (number of days) to 
relapse will be analyzed using the Kaplan–Meier method. The median time to relapse will be 
calculated in addition to other appropriate descriptive statistics. Patients who discontinue study  
ARQ-151-202 without relapse will be considered censored in the Kaplan–Meier analysis. 
12 STUDY ADMINISTRATION 
12.1 Ethics 
12.1.1 Ethics Review Board  
Before enrollment of patients into the study, the current protocol and ICF will be reviewed and 
approved by an appropriate IRB or IEC, as required by FDA (21 CFR § 56), Health Canada, and 
ICH GCP regulations.  A letter documenting the IRB or IEC approval must be received by the 
Sponsor before the initiation of the study at a clinical site. Amendments to the protocol will be 
subject to the same requirements as the original protocol.  
The Investigator, Sponsor, or designee will submit a progress report at least once yearly to the 
IRB or IEC. However, the frequency of these reports will depend on IRB or IEC requirements. 
As soon as possible after completion or termination of the study, the Investigator will submit a 
final report to the IRB or IEC per the IRB or IEC requirements, and in compliance with FDA and 
Health Canada regulations and ICH GCP guidelines. 
The Investigator, the Sponsor, or designee shall promptly notify the IRB or IEC of any SAEs, 
SUSARs, or any other information that may affect the safe use of the study drug(s) during the 
study, per the IRB or IEC local requirements, and in compliance with FDA and Health Canada 
regulations and ICH GCP guidelines. 
12.1.2 Ethical Conduct of the Study 
 
This research will be carried out in accordance with the protocol, the principles of the 
Tri-Council Policy Statement (TCPS), the ethical principles set forth in the Declaration of 
Helsinki, and the ICH harmonized tripartite guideline regarding GCP (E6 Consolidated 
Guidance, April 1996). 
 
 


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12.1.3 Subject Information and Consent 
 
The purpose of the study, the procedures to be carried out and the potential hazards will be 
described to the subjects in non-technical terms. Subjects will be required to read, sign and date 
an ICF summarizing the discussion prior to screening and will be assured that they may 
withdraw from the study at any time without jeopardizing their medical care. 
Subjects will be given a signed copy of their ICF. 
12.2 Study Monitoring 
Prior to the initiation of the clinical investigation, Sponsor representatives or designees will visit 
the clinical site where the investigation is to be conducted.  Sponsor representatives shall ensure 
that the Investigator understands the investigational status of the investigational product, all 
requirements of the investigation to be undertaken, and all of his/her responsibilities as an 
Investigator.  Sponsor representatives will also visit the clinical site at appropriate intervals as 
required to ensure compliance with the protocol and to verify the accuracy and completeness of 
data reported on the CRFs.  The Study Director or designees shall be available for consultation 
with the Investigator and serve as liaisons between the clinical site and the Sponsor. 
The Sponsor or authorized designees may inspect all documents and records required to be 
maintained by the Investigator, including but not limited to medical records (office, clinic, or 
hospital) and investigational product dispensation logs for the subjects in this clinical 
investigation.  The Investigator must permit access to such records.  The Investigator must 
obtain, as part of informed consent, permission for an authorized representative of the Sponsor, 
or regulatory authorities, to review, in confidence, any records identifying subjects. 
12.3 Data Quality Assurance 
In order to ensure the collection of accurate, consistent, complete, and reliable data during this 
clinical investigation, Sponsor representatives or designees may conduct audits of participating 
sites at appropriate intervals throughout the study.  The results of these periodic site audits may 
be subject to review by independent auditors at completion of the clinical investigation.   
The Clinical Study Report will be audited by the QST’s Research’s Quality Assurance (QA) 
department and the QA audit certificate will be included in the study report. 
All clinical data will undergo a 100% quality control check prior to clinical database lock. Edit 
checks are then performed for appropriate databases as a validation routine using SAS® to check 
for missing data, data inconsistencies, data ranges etc. Corrections are made prior to database 
lock. 
12.4 Data Handling and Record Keeping 
During the clinical study, the Investigator will maintain adequate records, including medical 
records, records detailing the progress of the study for each subject, laboratory reports, signed 
informed consent forms, investigational product disposition records, correspondence with the 
ERB/IRB and Study Monitor/Sponsor, AE reports, and information regarding subject 
discontinuation and completion of the clinical investigation. 


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All required study data will be recorded on eCRFs.  Any change of data will be recorded on the 
audit trail and a reason for the change will be entered.  
The principal investigator must retain all documentation relating to the study for a period of at 
least 2 years after the last marketing application approval or, if not approved, 2 years following 
the discontinuance of the test article for investigation.  If this requirement differs from any local 
regulations, the local regulations will take precedence unless the local retention policy is less 
than 2 years.   
12.5 Protocol Amendments and Deviations  
No change or amendment to this protocol may be made by the investigator or Sponsor after the 
protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) has 
(have) been agreed upon by the investigator and Sponsor.  Any change agreed upon will be 
recorded in writing, and the written amendment will be signed by the investigator and Sponsor.  
Institutional review board approval is required prior to the implementation of an amendment, 
unless overriding safety reasons warrant immediate action, in which case the IRB(s) will be 
promptly notified. 
No deviation from the protocol will be made except to protect the life or physical well-being of a 
subject in an emergency.  Except in such emergencies, prior approval of the Sponsor, and the 
IRB, is required before deviations from the planned protocol.  All protocol deviations that occur 
during the study will be documented and reported to Sponsor and to the IRB(s), if applicable, 
according to regulations.  Further details about the documentation, evaluation, and follow-up of 
protocol deviations are detailed in this study’s clinical monitoring plan.  
No waivers to inclusion/exclusion criteria will be granted; subjects need to meet all criteria, 
exactly as specified, to be enrolled.  Additionally, prospective deviations from the protocol or 
investigational plan are not permitted except to protect the life or physical well-being of a subject 
in an emergency.  Deviations that occur unintentionally or are the result of action by the subject 
must be documented and reported to the IRB(s), if applicable, according to regulations.  Further 
details about the documentation, evaluation, and follow-up of protocol deviations are detailed in 
this study’s clinical monitoring plan. 
12.6 Report Format 
According to the ICH Harmonized Tripartite Guideline (Organization of the Common Technical 
Document for the Registration of Pharmaceuticals for Human Use M4 and the ICH M2 Expert 
Working Group), the final report will be written according to the ICH E3 Guideline (Structure 
and Content of Clinical Study Reports).  
12.7 Publication Policy 
The Sponsor is supportive of publishing clinical trial findings.  The process of coordinating 
publication efforts is detailed in the Clinical Trial Agreement. 
 


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13 REFERENCES 
Berger, RS, Bowman JP. A reappraisal of the 21-day Cumulative Irritation Test in man.  
J. Toxicol Ot & Ocular Toxicol 1982:1(2);109-115. 
Bethke, TD, Lahu, G.  High absolute bioavailability of the new oral phosphodiesterase-4 
inhibitor roflumilast.  Int. J Clin Pharmacol Ther.  2011; 49:51-57. 
Brion DE, Raynaud F, Plet A, Laurent P, Leduc B, and Anderson W.  Deficiency of cyclic 
AMP-dependent protein kinases in human psoriasis.  Proc. Natl. Acad. Sci.  1986; 83:5272-5276. 
DALIRESP (roflumilast) tablets [package insert]. AstraZeneca Pharmaceuticals LP, Wilmington, 
DE USA; 2017. 
DAXAS (roflumilast) film-coated tablets [product monograph]. AstraZeneca Canada, Inc., 
Mississauga, Ontario Canada; 2017. 
Hatzelmann A, Morcillo EJ, Lungarella G, Adnot S, Sanjar S, Beume R, et al. The preclinical 
pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for 
chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2010; 23:235–256. 
Investigator’s Brochure, Edition 2.1, October 2018. 
Michalski, J. M., Golden, G., Ikari, J. and Rennard, S. I. (2012), PDE4: A Novel Target in the 
Treatment of Chronic Obstructive Pulmonary Disease. Clinical Pharmacology & Therapeutics, 
91: 134–142. 
Snape SD, Wigger-Alberti W, Goehring, UM.  A phase I randomized trial to assess the effect on 
skin inﬁltrate thickness and tolerability of topical phosphodiesterase inhibitors in the treatment of 
psoriasis vulgaris using a modiﬁed psoriasis plaque test.  Br J Dermatol.  2016; 175:479-486. 
Wedzicha, JA, Calverley, PMA, Klaus, FR.  Roflumilast: a review of its use in the treatment of 
COPD.  International Journal of Chronic Obstructive Pulmonary Disease (2016) 11:81-90. 


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14 APPENDICES 
Appendix 1. Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version 
 
COLUMBIA-SUICIDE SEVERITY 
RATING SCALE 
(C-SSRS)  
Baseline/Screening Version 
Version 1/14/09 
 
  
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
 
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained in 
the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of suicidal 
ideation or behavior depends on the judgment of the individual administering the scale. 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History Form, 
developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu 
© 2008 The Research Foundation for Mental Hygiene, Inc. 


Protocol ARQ-151-202 Amendment 1 
Arcutis, Inc. 
 
April 12, 2019 
Confidential 
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SUICIDAL BEHAVIOR 
(Check all that apply, so long as these are separate events; must ask about all types) 
 
Lifetime 
Past 
 
Years 
Actual Attempt:  
A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill 
oneself  Intent does not have to be 100%   If there is any intent/desire to die associated with the act, then it can be considered an actual suicide 
attempt  There does not have to be any injury or harm, just the potential for injury or harm  If person pulls trigger while gun is in 
mouth but gun is broken so no injury results, this is considered an attempt    
Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances  For example, a 
highly lethal act that is clearly not an accident so no other intent but suicide can be inferred (e g , gunshot to head, jumping from window of a 
high floor/story)  Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred   
Have you made a suicide attempt? 
Have you done anything to harm yourself? 
Have you done anything dangerous where you could have died? 
What did you do? 
Did you______ as a way to end your life?  
Did you want to die (even a little) when you_____?  
Were you trying to end your life when you _____? 
Or Did you think it was possible you could have died from_____? 
Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better,  
get sympathy, or get something else to happen)?  (Self-Injurious Behavior without suicidal intent) 
If yes, describe: 
 
Has subject engaged in Non-Suicidal Self-Injurious Behavior? 
Yes     No 
 
 
 
 
 
 
 
 
Total # of 
Attempts 
 
 
 
 
 
 
 
 
 
Yes     No 
 
Yes     No 
 
 
 
 
 
 
 
Total # of 
Attempts 
 
 
 
 
 
 
 
 
 
Yes     No 
 
Interrupted Attempt:   
When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would 
have occurred). 
Overdose: Person has pills in hand but is stopped from ingesting   Once they ingest any pills, this becomes an attempt rather than an interrupted 
attempt  Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger  Once 
they pull the trigger, even if the gun fails to fire, it is an attempt  Jumping: Person is poised to jump, is grabbed and taken down from ledge  
Hanging: Person has noose around neck but has not yet started to hang - is stopped from doing so  
Has there been a time when you started to do something to end your life but someone or something stopped you before 
you actually did anything? 
If yes, describe: 
 
Yes      No 
 
 
 
 
Total # of 
interrupted 
 
 
 
Yes     No 
 
 
 
Total # of 
interrupted 
 
 
 
Aborted Attempt:   
When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-
destructive behavior  Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by 
something else  
Has there been a time when you started to do something to try to end your life but you stopped yourself before you 
actually did anything? 
If yes, describe: 
 
Yes      No 
 
 
 
Total # of 
aborted 
 
 
Yes     No 
 
 
Total # of 
aborted 
 
 
Preparatory Acts or Behavior: 
Acts or preparation towards imminently making a suicide attempt  This can include anything beyond a verbalization or thought, such as 
assembling a specific method (e g , buying pills, purchasing a gun) or preparing for one’s death by suicide (e g , giving things away, writing a 
suicide note)   
Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, 
getting a gun, giving valuables away or writing a suicide note)? 
If yes, describe: 
 
 
 
Yes      No 
 
 
 
Yes     No 
 
Suicidal Behavior: 
Suicidal behavior was present during the assessment period? 
Yes      No 
 
Yes     No 
 
Answer for Actual Attempts Only 
Most Recent 
Attempt 
Date: 
Most Lethal        
Attempt 
Date: 
Initial/First 
Attempt 
Date: 
Actual Lethality/Medical Damage:   
0   No physical damage or very minor physical damage (e g , surface scratches)  
1   Minor physical damage (e g , lethargic speech; first-degree burns; mild bleeding; sprains)  
2   Moderate physical damage; medical attention needed (e g , conscious but sleepy, somewhat responsive; second-degree 
burns; bleeding of major vessel)  
3   Moderately severe physical damage; medical hospitalization and likely intensive care required (e g , comatose with reflexes 
intact; third-degree burns less than 20% of body; extensive blood loss but can recover; major fractures)  
4   Severe physical damage; medical hospitalization with intensive care required (e g , comatose without reflexes; third-degree 
burns over 20% of body; extensive blood loss with unstable vital signs; major damage to a vital area)  
5   Death 
Enter Code 
 
 
 
______ 
 
 
 
 
Enter Code 
 
 
 
______ 
 
 
 
Enter Code 
 
 
 
______ 
 
 
 
Potential Lethality: Only Answer if Actual Lethality=0 
Likely lethality of actual attempt if no medical damage (the following examples, while having no actual medical damage, had 
potential for very serious lethality: put gun in mouth and pulled the trigger but gun fails to fire so no medical damage; laying 
on train tracks with oncoming train but pulled away before run over)  
 
0 = Behavior not likely to result in injury 
1 = Behavior likely to result in injury but not likely to cause death 
2 = Behavior likely to result in death despite available medical care 
Enter Code 
 
 
 
______ 
 
 
Enter Code 
 
 
 
______ 
 
Enter Code 
 
 
 
______ 
 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Baseline/Screening (Version 1/14/09)    
 
 
                             Page 2 of 2     


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April 12, 2019 
Confidential 
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Appendix 2. Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version 
 
 
 
 
 
 
 
 
 
COLUMBIA-SUICIDE SEVERITY 
RATING SCALE 
(C-SSRS) 
Since Last Visit 
Version 1/14/09 
 
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
 
 
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained 
in the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of 
suicidal ideation or behavior depends on the judgment of the individual administering the scale. 
 
 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History 
Form, developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu 
 
© 2008 The Research Foundation for Mental Hygiene, Inc. 


Protocol ARQ-151-202 Amendment 1 
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April 12, 2019 
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 Page 61 of 69 
 
 
 
 
 
SUICIDAL IDEATION 
Ask questions 1 and 2.  If both are negative, proceed to “Suicidal Behavior” section. If the answer to question 2 is “yes”, 
ask questions 3, 4 and 5.  If the answer to question 1 and/or 2 is “yes”, complete “Intensity of Ideation” section below. 
 
Since Last 
Visit 
1.  Wish to be Dead  
Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up   
Have you wished you were dead or wished you could go to sleep and not wake up?  
 
If yes, describe: 
 
 
Yes       No 
 □    □ 
2.  Non-Specific Active Suicidal Thoughts 
General, non-specific thoughts of wanting to end one’s life/commit suicide (e g , “I’ve thought about killing myself”) without thoughts of ways to kill 
oneself/associated methods, intent, or plan during the assessment period   
Have you actually had any thoughts of killing yourself? 
 
If yes, describe: 
 
 Yes      No 
 □    □ 
3.  Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act 
Subject endorses thoughts of suicide and has thought of at least one method during the assessment period  This is different than a specific plan with time, 
place or method details worked out (e g , thought of method to kill self but not a specific plan)   Includes person who would say, “I thought about taking an 
overdose but I never made a specific plan as to when, where or how I would actually do it…and I would never go through with it.” 
Have you been thinking about how you might do this? 
 
If yes, describe: 
 
 Yes      No 
 □    □ 
4.  Active Suicidal Ideation with Some Intent to Act, without Specific Plan 
Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to “I have the thoughts but I 
definitely will not do anything about them.” 
Have you had these thoughts and had some intention of acting on them?  
 
If yes, describe: 
 
 
Yes       No 
 □    □ 
5.  Active Suicidal Ideation with Specific Plan and Intent 
Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out  
Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? 
   
If yes, describe: 
 
 
 Yes      No 
 □    □ 
INTENSITY OF IDEATION 
The following features should be rated with respect to the most severe type of ideation (i.e., 1-5 from above, with 1 being the least severe 
and 5 being the most severe).  
                                             
Most Severe Ideation:             _____                      _________________________________________________ 
                                               
                                                                                                           Type # (1-5)                                         Description of  Ideation 
Most 
Severe 
Frequency 
How many times have you had these thoughts?  
(1) Less than once a week    (2) Once a week   (3)  2-5 times in week    (4) Daily or almost daily    (5) Many times each day 
 
____ 
Duration 
When you have the thoughts, how long do they last? 
(1) Fleeting - few seconds or minutes                                                 (4) 4-8 hours/most of day 
(2) Less than 1 hour/some of the time                                                 (5) More than 8 hours/persistent or continuous 
(3) 1-4 hours/a lot of time                                                                    
____ 
Controllability 
Could/can you stop thinking about killing yourself or wanting to die if you want to? 
(1) Easily able to control thoughts                                                      (4) Can control thoughts with a lot of difficulty 
(2) Can control thoughts with little difficulty                                     (5) Unable to control thoughts 
(3) Can control thoughts with some difficulty                                    (0) Does not attempt to control thoughts 
____ 
Deterrents 
Are there things - anyone or anything (e.g., family, religion, pain of death) - that stopped you from wanting to die or acting on 
thoughts of committing suicide? 
(1) Deterrents definitely stopped you from attempting suicide            (4) Deterrents most likely did not stop you  
(2) Deterrents probably stopped you                                                    (5) Deterrents definitely did not stop you  
(3) Uncertain that deterrents stopped you                                             (0) Does not apply 
____ 
Reasons for Ideation 
What sort of reasons did you have for thinking about wanting to die or killing yourself?  Was it to end the pain or stop the way 
you were feeling (in other words you couldn’t go on living with this pain or how you were feeling) or was it to get attention, 
revenge or a reaction from others? Or both? 
(1) Completely to get attention, revenge or a reaction from others       (4) Mostly to end or stop the pain (you couldn’t go on 
(2) Mostly to get attention, revenge or a reaction from others                     living with the pain or how you were feeling) 
(3) Equally to get attention, revenge or a reaction from others               (5) Completely to end or stop the pain (you couldn’t go on  
       and to end/stop the pain                                                                         living with the pain or  how you were feeling) 
                                                                                                                 (0)  Does not apply 
 
 
 
 
____ 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Since Last Visit (Version 1/14/09)    
 
 
                          Page 1 of 2        


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April 12, 2019 
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 Page 62 of 69 
 
 
 
 
SUICIDAL BEHAVIOR 
(Check all that apply, so long as these are separate events; must ask about all types) 
Since Last 
Visit 
Actual Attempt:  
A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill oneself  Intent 
does not have to be 100%   If there is any intent/desire to die associated with the act, then it can be considered an actual suicide attempt  There does not 
have to be any injury or harm, just the potential for injury or harm  If person pulls trigger while gun is in mouth but gun is broken so no injury results, 
this is considered an attempt    
Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances  For example, a highly 
lethal act that is clearly not an accident so no other intent but suicide can be inferred (e g , gunshot to head, jumping from window of a high floor/story)  
Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred   
Have you made a suicide attempt? 
Have you done anything to harm yourself? 
 
Have you done anything dangerous where you could have died? 
What did you do? 
Did you______ as a way to end your life?  
Did you want to die (even a little) when you_____?  
Were you trying to end your life when you _____? 
Or did you think it was possible you could have died from_____? 
Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better, get 
sympathy, or get something else to happen)?  (Self-Injurious Behavior without suicidal intent) 
If yes, describe: 
 
 
Has subject engaged in Non-Suicidal Self-Injurious Behavior? 
 
Yes      No 
□   □ 
 
 
 
 
 
 
 
Total # of 
Attempts 
 
 
 
 
 
 
 
 
 
Yes     No 
□   □ 
Interrupted Attempt:   
When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would have 
occurred). 
Overdose: Person has pills in hand but is stopped from ingesting   Once they ingest any pills, this becomes an attempt rather than an interrupted attempt  
Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger  Once they pull the trigger, 
even if the gun fails to fire, it is an attempt  Jumping: Person is poised to jump, is grabbed and taken down from ledge  Hanging: Person has noose around 
neck but has not yet started to hang - is stopped from doing so  
Has there been a time when you started to do something to end your life but someone or something stopped you before you 
actually did anything? 
If yes, describe: 
 
Yes      No 
□   □ 
 
 
Total # of 
interrupted 
 
 
Aborted Attempt:   
When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-destructive behavior  
Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by something else  
Has there been a time when you started to do something to try to end your life but you stopped yourself before you 
actually did anything? 
If yes, describe: 
 
 
Yes      No 
□   □ 
 
Total # of 
aborted 
 
 
Preparatory Acts or Behavior: 
Acts or preparation towards imminently making a suicide attempt  This can include anything beyond a verbalization or thought, such as assembling a 
specific method (e g , buying pills, purchasing a gun) or preparing for one’s death by suicide (e g , giving things away, writing a suicide note)   
Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, getting a gun, 
giving valuables away or writing a suicide note)? 
If yes, describe: 
 
 
Yes      No 
□   □ 
Suicidal Behavior: 
Suicidal behavior was present during the assessment period? 
Yes      No 
□   □ 
Suicide: 
   Yes    No 
□   □ 
Answer for Actual Attempts Only 
Most Lethal 
Attempt 
Date: 
Actual Lethality/Medical Damage:   
0   No physical damage or very minor physical damage (e g , surface scratches)  
1   Minor physical damage (e g , lethargic speech; first-degree burns; mild bleeding; sprains)  
2   Moderate physical damage; medical attention needed (e g , conscious but sleepy, somewhat responsive; second-degree burns; bleeding of major vessel)  
3   Moderately severe physical damage; medical hospitalization and likely intensive care required (e g , comatose with reflexes intact; third-degree burns 
less than 20% of body; extensive blood loss but can recover; major fractures)  
4   Severe physical damage; medical hospitalization with intensive care required (e g , comatose without reflexes; third-degree burns over 20% of body; 
extensive blood loss with unstable vital signs; major damage to a vital area)  
5   Death 
 
Enter Code 
 
 
 
______ 
Potential Lethality: Only Answer if Actual Lethality=0 
Likely lethality of actual attempt if no medical damage (the following examples, while having no actual medical damage, had potential for very serious 
lethality: put gun in mouth and pulled the trigger but gun fails to fire so no medical damage; laying on train tracks with oncoming train but pulled away 
before run over)  
 
0 = Behavior not likely to result in injury 
1 = Behavior likely to result in injury but not likely to cause death 
2 = Behavior likely to result in death despite available medical care  
 
Enter Code 
 
 
 
______ 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Since Last Visit (Version 1/14/09)    
 
 
                          Page 2 of 2                                     















SAP_001.pdf: 
 
 
Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
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CONFIDENTIAL
STATISTICAL ANALYSIS PLAN
Protocol Number:
ARQ-151-202
Study Title:
A Phase 2, Multicenter, Open-Label 
Extension Study of the 
Long-Term Safety of ARQ-151 Cream 
0.3% in Adult Subjects 
with Chronic Plaque Psoriasis who have 
Completed Preceding
Study ARQ-151-201 Phase 2 
Randomized Controlled Trial
(Cohort 1) and non-ARQ-151-201 
Subjects (Cohort 2)
Development Phase of Study:
Phase 2
Sponsor:
Arcutis Biotherapeutics, Inc.
2945 Townsgate Road, Suite 110 
Westlake Village, CA 91361 
USA
Sponsor Contact:
Statistical Analysis Plan based on Protocol Version:
Version 1.0 Amendment 1,  25 March 
2019
Statistical Analysis Plan Date:
22OCT2020
Statistical Analysis Plan Version:
Version 1




 
 
Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
TOOL.ST.101-01.02 Statistical Analysis Plan Template          
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CONFIDENTIAL
SAP Change History
Version
Date
Summary of Changes 
Author
1 22 OCT 2020 
Original document 
 


 
 
Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
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CONFIDENTIAL
TABLE OF CONTENTS
1.
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ....................................6
2.
INTRODUCTION .................................................................................................................6
3.
STUDY OBJECTIVES .........................................................................................................7
4.
STUDY DESIGN ...................................................................................................................8
4.1 Overall Study Design ......................................................................................................8
4.1.1
Schedule of Visits and Assessments .................................................................8
4.1.2
Method of Assigning Subjects to Treatment Groups ........................................8
4.1.3 
Blinding .............................................................................................................8
5.
EFFICACY AND SAFETY ENDPOINTS .........................................................................8
5.1 Safety Endpoints .............................................................................................................8
5.2 Efficacy Endpoints ..........................................................................................................9
6.
STATISTICAL AND ANALYTICAL PLANS ................................................................11
6.1 General Methodology ...................................................................................................11
6.1.1 
Statistical Analysis ..........................................................................................11
6.1.2 
Baseline Definition ..........................................................................................11
6.1.3 
Visit Windowing .............................................................................................12
6.1.4 
Adjustments for Covariates .............................................................................12
6.1.5 
Handling of Dropouts or Missing Data ...........................................................12
6.1.6 
Interim Analyses and Data Monitoring ...........................................................12
6.1.7 
Multicenter Studies ..........................................................................................13
6.1.8 
Multiple Comparisons/Multiplicity .................................................................13
6.1.9 
Use of an Efficacy Subset of Subjects .............................................................13
6.1.10 Active-Control Studies Intended to Show Equivalence ..................................13
6.1.11 Examination of Subgroups ..............................................................................13
6.2 Disposition of Subjects .................................................................................................13
6.3 Protocol Deviations .......................................................................................................13
6.4 Data Sets Analyzed .......................................................................................................13
6.4.1 
Safety Population.............................................................................................13
6.5 Demographic and Other Baseline Characteristics ........................................................14
6.6 Prior and Concomitant Medications .............................................................................14
6.7 Analysis of Efficacy ......................................................................................................14


 
 
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Date: 22OCT2020
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6.8 Safety Evaluation ..........................................................................................................15
6.8.1 
Extent of Exposure ..........................................................................................15
6.8.2 
Adverse Events ................................................................................................15
6.8.3 
Clinical Laboratory Evaluation .......................................................................16
6.8.4 
Other Observations Related to Safety .............................................................16
6.8.4.1
12-Lead Electrocardiogram Measurements .................................16
6.8.4.2
Vital Signs ....................................................................................17
6.8.4.3
Physical Examination...................................................................17
6.8.4.4
Local Tolerance Assessments ......................................................17
6.8.4.5
Patient Health Questionnaire Depression Scale ...........................17
6.8.4.6
Columbia-Suicide Severity Rating Scale .....................................17
6.8.4.7
Prior and Concomitant Medication ..............................................18
7.
DETERMINATION OF SAMPLE SIZE .........................................................................18
8.
CHANGES IN THE PLANNED ANALYSES ..................................................................18
9.
REFERENCES ....................................................................................................................20
10.
INDEX OF PLANNED TABLES ......................................................................................21
11.
INDEX OF PLANNED LISTINGS .................................................................................302


 
 
Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
TOOL.ST.101-01.02 Statistical Analysis Plan Template          
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CONFIDENTIAL
1.
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
AE(s)
adverse event(s)
ATC
anatomical therapeutic chemical
cm
centimeters
C-SSRS 
Columbia-Suicide Severity Rating Scale
ECG
electrocardiogram 
IGA
Investigator Global Assessment
I-IGA
Intertriginous Investigator Global Assessment
kg
kilograms
max
maximum
MedDRA
Medical Dictionary for Regulatory Activities
min
minimum
mPASI
Modified Psoriasis Area Severity Index
mPASI-75
75% reduction from Baseline of Modified Psoriasis Area Severity Index
n
number of observations 
N 
number of subjects (sample size)
PASI-50 
50% reduction from Baseline of Psoriasis Area Severity Index 
PASI-75
75% reduction from Baseline of Psoriasis Area Severity Index
PHQ-8
Patient Health Questionnaire Depression Scale
QST
QST Consultations, Ltd. 
SAE(s)
serious adverse event(s)
SAS®
Statistical Analysis System (SAS® Institute Inc., Cary, NC)
SD
standard deviation
SOC
system organ class
TEAE(s)
treatment-emergent adverse event(s)
US
United States
WHO
World Health Organization 
WHO-DD
World Health Organization Drug Dictionary
2.
INTRODUCTION
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated
with chronic bronchitis. Roflumilast and its active metabolite, roflumilast N-oxide, are high 


 
 
Statistical Analysis Plan
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Version: 1 
Date: 22OCT2020
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CONFIDENTIAL
affinity selective inhibitors of PDE-4 (a major cyclic-
-adenosine monophosphate (cyclic 
AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular cyclic AMP.
There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and PDE-4d, each with 
several isoforms (splicing variants). IC50 values of both roflumilast and roflumilast N-oxide for 
the different PDE-4 isoforms and subtypes are mostly sub-nanomolar and single digit nanomolar 
(Hatzelmann 2010). The PDE-4 family of enzymes are the most prevalent phosphodiesterases in
immune cells and inhibition of PDE-4 subtypes has been associated with anti-inflammatory
effects in many biological systems.
Psoriasis is a chronic inflammatory skin disease characterized by raised, well-demarcated,
erythematous oval plaques with adherent silvery scales. Numerous past reports have suggested a 
deficiency of cyclic AMP-dependent protein kinases in human psoriatic skin (Brion 1986). More 
recently, various cytokines produced by Th1 and Th17 cells have been shown to play a crucial 
role in the pathogenesis of psoriasis. It has been postulated that the anti-inflammatory effects of
PDE-4 inhibitors may provide a beneficial therapeutic intervention in the treatment of chronic 
plaque psoriasis and recently Otezla® (apremilast), a PDE-4 inhibitor, has been approved for the 
oral treatment of chronic plaque psoriasis.  
The past 15 years have witnessed a transformation in the systemic treatment of moderate to 
severe psoriasis with the advent of biological therapies. However, for patients with milder forms 
of disease, best treated with topical options, the therapeutic landscape really has not changed in
several decades. Topical steroids come in all shapes and forms, but the lower potency steroids 
are not effective and the higher potency steroids are beset with issues of local skin atrophy and
the potential for hypothalamic-pituitary axis suppression when applied over larger body surface 
areas and for prolonged periods of time. Vitamin D has been the other staple of topical psoriasis 
treatment but it is irritating, not suitable for use on the face or intertriginous areas, and its
efficacy is rather modest. Hence, there is substantial medical need for additional topical
approaches in the treatment of psoriasis. The study sponsor is developing a topical formulation 
of roflumilast for the treatment of chronic plaque psoriasis. Our Phase 2a results suggest that
ARQ-151 may be a highly efficacious and well-tolerated topical treatment for psoriasis.
3.
STUDY OBJECTIVES
The objective of this study is to assess long-term safety in a multicenter, open-label, 52-week
study in subjects treated with ARQ-151 cream 0.3% after completing a 12-week Phase 2b study 
(ARQ-151-201) Cohort 1 and non ARQ-151-201 subjects (Cohort 2). 


 
 
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4.
STUDY DESIGN
4.1
Overall Study Design 
This is an open-label, long-term safety study of ARQ-151 cream 0.3% in subjects with chronic 
plaque psoriasis involving between 0 and 25% BSA. Eligible subjects will enroll into the long-
term safety study on the same day as the Week 12 visit for the previous study (ARQ-151-201) 
for Cohort 1 and on Day 1 for non ARQ-151-201 subjects in Cohort 2. Study medication will be 
applied by the subjects topically once a day for 52 weeks at home.
A total of up to approximately 300 subjects (Cohort 1) and up to approximately 100 non ARQ-
151-201 subjects (Cohort 2) will be enrolled at approximately 30 study sites in the United States 
and Canada. Subjects will be adult ( 18 y/o) males or females with chronic plaque psoriasis.
Periodic clinic visits will include assessments for clinical safety, application site reactions
evaluated in the clinic using the method of Berger and Bowman (Berger-1982), disease 
improvement or progression, and investigator global assessment (IGA). 
4.1.1
Schedule of Visits and Assessments
The schedule of assessments can be found in Section 5 of the protocol.
4.1.2
Method of Assigning Subjects to Treatment Groups
This is an open-label single-arm study. Eligible subjects will receive ARQ-151 cream 0.3%. 
4.1.3
Blinding
Not applicable. 
5.
EFFICACY AND SAFETY ENDPOINTS
5.1
Safety Endpoints
The primary endpoint will be analysis of safety monitored through application site assessments 
in the clinic using the method of Berger and Bowman, clinical laboratory testing, 12-lead 
electrocardiograms (ECGs), Patient Health Questionnaire Depression Scale (PHQ-8), Columbia-
Suicide Severity Rating Scale (C-SSRS) and adverse events (AEs). Two primary endpoint 
analyses are planned:
Occurrence of treatment emergent AEs (TEAEs)
Occurrence of Serious Adverse Events (SAEs)


 
 
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Additionally a set of secondary endpoints will be summarized. These include: 
Changes in PHQ-8, C-SSRS, ECG, clinical laboratory parameters, and vital signs over 
time.
Incidence of 5% of weight loss or gain from baseline. 
Incidence of shifts from baseline to last, highest and lowest BMI category.
Incidence of application site reactions assessed by the investigator.
5.2
Efficacy Endpoints
The secondary endpoints are related to efficacy and will include:
Proportion (%) of subjects achieving an IGA of clear or almost clear, as observed at 
Week 4, 12, 24, 36, and 52. 
In subjects who achieve ‘Clear’ scores for IGA, Intertriginous IGA (I-IGA) (if applicable 
and Modified Psoriasis Area Severity Index (mPASI)) and stop treatment to all lesions, 
time to restarting study drug (treatment free interval). Subjects with continual clearance 
will be censored at their date of last contact.
The incidence of subjects who stop therapy during the study due to disease clearance on 
study.  Disease clearance is defined as ‘Clear’ scores for IGA, I-IGA (if applicable and 
mPASI).    
Proportion (%) of applicable subjects with intertriginous area involvement, ‘I-IGA’ score
of ‘Clear’ or ‘Almost Clear’ at Week 4, 12, 24, 36, and 52. 
Proportion (%) of subjects achieving a 75% reduction from Baseline of PASI (PASI-75) 
at Week 4, 12, 24, 36, and 52. PASI was not specifically collected but will be derived 
based on already reported information.  
Proportion (%) of subjects achieving a 75% reduction from Baseline of mPASI (mPASI-
75) at Week 4, 12, 24, 36, and 52. 
Proportion of subjects (%) with a 2-grade improvement in IGA from Baseline as 
observed at Weeks 4, 12, 24, 36, 52. 
Proportion of subjects (%) with IGA Success, defined as achievement of an IGA of 
‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement in IGA from Baseline as observed 
at Weeks 4, 12, 24, 36, and 52. 


 
 
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Duration of IGA Success, defined as the time from the first observation of IGA Success 
to the first subsequent time a subject’s disease response does not meet the criteria for 
IGA Success. The duration of IGA Success for subjects who end treatment in IGA 
Success will be censored at the last disease assessment date. 
Duration of IGA Clear or Almost Clear, defined as the time from the first observation of 
IGA Clear or Almost Clear to the first subsequent time a subject’s disease response is not 
Clear or Almost Clear.  The duration of IGA Clear or Almost Clear for subjects who end 
treatment with IGA Clear or Almost Clear will be censored at the last disease assessment 
date.
Duration of PASI-50, defined as the time from the first observation of a 50% reduction 
from Baseline in the PASI to the first subsequent time a subject’s PASI score is greater 
than a 50% reduction from Baseline.  The duration of PASI-50 for subjects who end 
treatment with PASI score at least 50% less than Baseline will be censored at the last 
disease assessment date.
Duration of PASI-75, defined analogously to duration of PASI-50 
Percent change from baseline in PASI score at each disease assessment
Shift from the baseline IGA score to the last reported IGA score on study
Frequency of disease recurrence among subjects who stop therapy due to disease 
clearance. Disease recurrence is defined as any instance where IGA is  2 or mPASI is 
greater than 0.
Time to disease recurrence among subjects who stop therapy due to disease clearance.  
Time to disease recurrence is defined as the time from the last dose of ARQ-151 to the 
first observation of an IGA score of 2 or greater.  The time to disease recurrence among 
subjects with clearance at the end of the study observation period will be censored at the 
last observed disease assessment
The incidence of disease control among subjects who restart therapy after having stopped 
therapy due to disease clearance.  Disease control is defined as achieving an IGA score of 
0 or 1 subsequent to restarting study therapy.
Time to disease control among subjects who restart therapy after having stopped therapy 
due to disease clearance.  Time to disease control is the time from the restart of therapy to 
the first reported IGA score of 0 or 1. The time to disease control among subjects who do 
not achieve an IGA score of 0 or 1 by the end of the study observation period will be 
censored at the last observed disease assessment.


 
 
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6.
STATISTICAL AND ANALYTICAL PLANS
6.1
General Methodology
All statistical processing will be performed using SAS® (Version 9.4 or later) unless otherwise 
stated. 
Descriptive statistics will be used to provide an overview of the safety and efficacy results. For 
categorical parameters, the number and percentage of subjects in each category will be
presented. The denominator for percentage will be based on the number of subjects appropriate 
for the purpose of analysis. For continuous parameters, descriptive statistics will include number 
of subjects (n), mean, standard deviation (SD), median, minimum (min), and maximum (max).
Reported AEs, medical history terms and prior and concomitant procedures and therapies will be 
classified on the basis of Medical Dictionary for Regulatory Activities (MedDRA) terminology.  
Prior and concomitant medications will be classified on the basis of World Health Organization 
Drug Dictionary (WHO-DD) terminology.
6.1.1
Statistical Analysis 
All analyses outlined herein will be performed by QST Consultations, Ltd. (QST), utilizing
SAS® Version 9.4 or later.  All summary tables and data listings will be prepared utilizing 
SAS® software.
The standard operating procedures (SOPs) of QST, will be followed in the creation and quality 
control of all data displays and analyses described in this SAP. 
6.1.2
Baseline Definition
For subjects in Cohort 1, the baseline value for safety and efficacy parameters will be defined as 
the last observation prior to the first dose of ARQ-151 cream in either the ARQ-151-201 study or 
this study. Sensitivity analyses of efficacy will be performed where the baseline value for 
subjects in Cohort 1 is defined as the last observation prior to the first dose of ARQ-151 0.3% 
cream in this study.  For the purpose of these latter analyses, study procedures will not be 
repeated; the information from the ARQ-151-201 study Week 12 visit will be carried over to the 
Day 1 visit for this study.  
For subjects in Cohort 2, baseline values for efficacy and safety will be defined as the last 
observation prior to the first dose of ARQ-151 cream 0.3% in this study. Baseline values will 
most commonly be from Day 1. 


 
 
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6.1.3
Visit Windowing
Data will be summarized based on nominal visit indications with the exception of data captured 
at early termination and unscheduled visits. Data from early termination and unscheduled visits 
will be mapped to the most appropriate visit values based on the midpoints between scheduled 
visits. The analysis windows for early termination and unscheduled visits are presented in the 
following table.   
Analysis Windows for Efficacy and Safety Assessments
Scheduled Visit 
Target Study Day 
Window (Days) 
Week 4
29
15 to 57
Week 12
85
  58 to 127 
Week 24
169
128 to 211 
Week 36
253
212 to 309
Week 52 
365
>= 310
Data collected at early termination and unscheduled visits prior to study day 15 will not be 
analyzed, with the exception of those identified as baseline values.
For Cohort 1 subjects that were on the ARQ-151 cream 0.15% or ARQ-151 cream 0.3% arm in
the Phase 2b Study (ARQ-151-201), efficacy summaries will be presented for the ARQ-151-201 
visits as defined in ARQ-151-201 SAP. 
For time to event analysis, no visit windowing will be done. The real study day will be used and 
all assessments will be eligible for analysis.  
6.1.4
Adjustments for Covariates
No covariates are planned for this study. 
6.1.5
Handling of Dropouts or Missing Data 
Missing data will not be imputed.
6.1.6
Interim Analyses and Data Monitoring 
No interim inferential analysis or data monitoring is planned for this study. 


 
 
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6.1.7
Multicenter Studies
The clinical study will be conducted under a common protocol for each investigational site with 
the intention of pooling the data for analysis. Every effort will be made to promote consistency 
in study execution at each investigational site. 
6.1.8
Multiple Comparisons/Multiplicity
No inferential statistical analyses are planned.
6.1.9
Use of an Efficacy Subset of Subjects
No subset of subjects will be used for efficacy.
6.1.10
Active-Control Studies Intended to Show Equivalence
Not applicable to this study.  
6.1.11
Examination of Subgroups
Summaries will be presented for the safety based on previous treatment in ARQ-151-201, and a 
combined ARQ-151-201 group. Additionally summaries will be presented for a complement set 
of subjects that did not previously participate in ARQ-151-201. 
6.2
Disposition of Subjects
The number of subjects included in the safety population will be summarized by previous 
treatment group and cohort.  The number of subjects enrolled, completed, discontinued 
(including the reasons for discontinuation), and duration of participation (weeks) will be also be 
summarized. Duration of participation (weeks) is defined as (last contact date – date of first dose 
in ARQ-151-202 + 1) / 7. 
6.3
Protocol Deviations 
All protocol deviations that occur will be documented and reported to Arcutis Biotherapeutics
Inc. 
6.4
Data Sets Analyzed 
6.4.1
Safety Population
All subjects who are enrolled and received at least one confirmed dose of ARQ-151 cream 
0.15% or ARQ-151 cream 0.3% study medication in either the Phase 2b Study (ARQ-151-201) 


 
 
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or this extension study. The number of patients included in the safety population will be 
summarized. All analyses will be performed using the safety population. 
6.5
Demographic and Other Baseline Characteristics
All baseline summaries will be done on the safety population. 
Sex, race, and ethnicity will be summarized by counts and percentages. Age (years) will be 
summarized with descriptive statistics.
IGA, I-IGA, BSA, PASI, mPASI, Height, and Weight, will be summarized at baseline with 
descriptive statistics.
Past/coexistent medical history information and physical examination observations and vital 
signs information for all subjects will be presented in a by-subject listing.
6.6
Prior and Concomitant Medications 
Prior and concomitant medication information for all subjects will be presented in a by-subject 
listing. Summary tables will be presented by World Health Organization-Anatomical
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product.  
A by-subject listing of all prior and concomitant medications will be presented. 
6.7
Analysis of Efficacy
This study is not intended to assess efficacy, but rather the IGA, I-IGA, PASI and mPASI are 
included to determine the need for treatment and subsequent re-treatment after treatment course 
in Study ARQ-151-201 or Study ARQ-151-202. Certain efficacy data and endpoints will, 
however, be summarized. Descriptive statistics will be used to summarize the assessment of 
efficacy. IGA scores will be summarized at Baseline and every scheduled visit through end of 
the study (Day 1 and Weeks 4, 12, 24, 36, and 52). The efficacy variable in this study is success 
in IGA of disease severity, defined as an IGA of ‘Clear’ or ‘Almost Clear’. The number and 
percentage of patients who achieve treatment success at the scheduled study visits will be 
tabulated. The proportion of successes for the secondary variables of IGA, I-IGA, PASI-75 and 
mPASI-75 will be tabulated in a similar manner.
In subjects who achieve ‘Clear’ scores for IGA, I-IGA (if applicable) and mPASI (if applicable) 
and stop treatment to all lesions, time to restarting study drug (treatment free interval) will be 
calculated and analyzed. For Cohort 2 and rollover subjects previously treated with Vehicle 
Cream, the treatment free interval will be the number of weeks between the end of the initial 


 
 
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treatment in study ARQ-151-202 and the start of the next treatment in study ARQ-151-202 if one 
should be needed or the end of the subject’s participation in study ARQ-151-202. In the event 
that the subject’s participation in the study ends without a second round of treatment, subjects 
will be censored at last observed disease assessment. For rollover subjects previously treated 
with ARQ-151 cream 0.3% or ARQ-151 cream 0.15%, the treatment free interval will be the 
number of days between the last treatment that began in Study ARQ-151-201 and the start of the 
next treatment in study ARQ-151-202 if one should be needed or the last observed disease 
assessment in the study ARQ-151-202. Subjects who were lost to follow up will be included 
using all available information. The duration of IGA success, PASI-50, PASI-75, time to disease 
recurrence, time to disease control will be calculated in the same manner. 
The median time (number of weeks) for duration summaries will be analyzed using the Kaplan–
Meier method and will be accompanied with a plot. Patients who discontinue study ARQ-151-
202 without achieving the event of interest will be considered censored in the Kaplan–Meier 
analyses.
6.8
Safety Evaluation 
The following analyses will be performed; however, no formal inferential statistics will be done 
on safety assessments.
6.8.1
Extent of Exposure 
The extent of exposure to study drug in each treatment group will be summarized by total 
number of applications and total amount of study drug applied.  Total amount of study drug will 
be calculated as the difference between tube weights at dispensation and return. The number and 
percentage of subjects who are compliant in each treatment group will be summarized. Subjects 
may not miss more than three consecutive days of dosing and must take at least 80% of expected 
doses to be considered compliant.  
Subjects who were lost to follow up will be included in the total number of applications and total 
amount of study drug applied summaries, using their last known dose date. 
6.8.2
Adverse Events
All TEAEs that occur during the study will be recorded and coded based on the MedDRA 
dictionary, version 21.1. TEAEs are defined as AEs with an onset on or after the date of the first 
study drug application in this study. 
TEAEs will be summarized by treatment group, the number of subjects reporting a TEAE, 
system organ class (SOC), preferred name, severity, relationship to study drug (causality), and 


 
 
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seriousness. When summarizing AEs by severity and relationship, each subject will be counted 
once within an SOC or a preferred term by using the event with the highest severity and 
strongest relationship within each classification. Summaries of post active treatment emergent 
AEs (PATEAE) will also be presented. PATEAEs are defined as any AE that occurs after the 
first dose of ARQ-151 cream in either study. 
Serious AEs (SAEs) will be summarized by treatment group, severity and relationship to study 
drug, and individual SAEs will be listed by subject. In addition, a list of subjects who 
prematurely discontinue from the study due to an AE, or experience an AE leading to death will 
be provided. 
Listings will be presented for all AEs as well as for SAEs, and AEs leading to discontinuation 
from the study or death. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding study drug, corrective treatment, outcome, and drug 
relatedness. The event onset will also be shown relative (in number of days) to date of first 
application. In addition, listings of SAEs and subjects who prematurely discontinue from the 
study due to adverse events will also be provided. 
6.8.3
Clinical Laboratory Evaluation 
Routine blood chemistries and urinalysis will be obtained throughout the study and the results 
summarized by parameter at baseline andscheduled ARQ-151-202 study visits.  
All clinical laboratory test results and their change from baseline will be summarized along with 
time point of collection.  
Additionally, shifts tables will be provided describing out-of-normal range shifts for clinical 
laboratory results.  
6.8.4
Other Observations Related to Safety
6.8.4.1
12-Lead Electrocardiogram Measurements
Electrocardiograms (ECGs) will be tabulated at baseline and scheduled ARQ-151-202 study 
visits.  


 
 
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6.8.4.2
Vital Signs
Vital signs will be tabulated at baseline and scheduled ARQ-151-202 study visits. Additionally, a 
shift table will be used to summarize incidence of subjects who gain or lose >5% and >10% body 
weight over the course of the study. Any subject who gained or lost >5% body weight will be 
summarized in a listing with subject reported reason for weight loss (intentional, unintentional).
The incidence of shifts from baseline to last, highest, and lowest BMI category (underweight 
(BMI < 18.5), normal weight (18.5  BMI < 25), overweight (25  BMI < 30), obese (30 
BMI) will be presented in shift tables.
6.8.4.3
Physical Examination
Physical examination data will be presented in a by-subject listing.  
6.8.4.4
Local Tolerance Assessments 
For the Investigator’s assessment the numeric application site reaction scores will be summarized 
individually by using the number and percentage of subjects by visit. 
6.8.4.5
Patient Health Questionnaire Depression Scale
PHQ-8 data will be analyzed by a shift in state of severity using the following scoring system: 
Score
Result
  0 to 4 
None – Minimal Depression
5 to 9
Mild Depression
10 to 14 
Moderate Depression
15 to 19
Moderately Severe Depression
20 to 24
Severe Depression
6.8.4.6
Columbia-Suicide Severity Rating Scale
The C-SSRS will be analyzed per the C-SSRS Scoring and Data Analysis Guide.  


 
 
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6.8.4.7
Prior and Concomitant Medication  
Prior and concomitant medication information for all subjects will be presented in a by-subject 
listing. Summary tables will be presented by World Health Organization-Anatomical
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product.
7.
DETERMINATION OF SAMPLE SIZE
A sample size of approximately 300 subjects is planned for Cohort 1 and up to approximately 
100 subjects in Cohort 2 is planned for the study. This sample size will provide a sufficient 
population size to evaluate the long-term safety of ARQ-151 cream 0.3%. 
8.
CHANGES IN THE PLANNED ANALYSES
The definition of baseline for Cohort 1 was changed to: the baseline value for safety and efficacy 
parameters (excluding laboratory and vital signs values) will be defined as the last observation 
prior to the first dose of ARQ-151 cream in either the ARQ-151-201 study or this study. 
Sensitivity analyses of IGA and PASI efficacy will be performed where the baseline value for 
subjects in Cohort 1 is defined as the last observation prior to the first dose of ARQ-151 0.3% 
cream in this study.  For the purpose of these latter analyses, study procedures will not be 
repeated; the information from the ARQ-151-201 study Week 12 visit will be carried over to the 
Day 1 visit for this study. 
Week 4 was added to the following secondary endpoints. 
Proportion (%) of subjects achieving an IGA of clear or almost clear
Proportion (%) of applicable subjects with intertriginous area involvement, ‘I-IGA’ score 
of ‘Clear’ or ‘Almost Clear’
Proportion (%) of subjects achieving a 75% reduction from Baseline of mPASI (mPASI-
75) 
The following secondary endpoints were added to the analyses. 
Incidence of shifts from baseline to last, highest and lowest BMI category.
The incidence of subjects who stop therapy during the study due to disease clearance on 
study.  Disease clearance is defined as ‘Clear’ scores for IGA, I-IGA (if applicable and 
mPASI).


 
 
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Proportion (%) of subjects achieving a 75% reduction from Baseline of PASI (PASI-75) 
at Week 4, 12, 24, 36, and 52. PASI was not specifically collected but will be derived 
based on already reported information.  
Proportion (%) of subjects achieving a 75% reduction from Baseline of mPASI (mPASI-
75) at Week 4, 12, 24, 36, and 52. 
Proportion of subjects (%) with a 2-grade improvement in IGA from Baseline as 
observed at Weeks 4, 12, 24, 36, 52. 
Proportion of subjects (%) with IGA Success, defined as achievement of an IGA of 
‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement in IGA from Baseline as observed 
at Weeks 4, 12, 24, 36, and 52. 
Duration of IGA Success, defined as the time from the first observation of IGA Success 
to the first subsequent time a subject’s disease response does not meet the criteria for 
IGA Success. The duration of IGA Success for subjects who end treatment in IGA 
Success will be censored at the last disease assessment date. 
Duration of IGA Clear or Almost Clear, defined as the time from the first observation of 
IGA Clear or Almost Clear to the first subsequent time a subject’s disease response is not 
Clear or Almost Clear.  The duration of IGA Clear or Almost Clear for subjects who end 
treatment with IGA Clear or Almost Clear will be censored at the last disease assessment 
date.
Duration of PASI-50, defined as the time from the first observation of a 50% reduction 
from Baseline in the PASI to the first subsequent time a subject’s PASI score is greater 
than a 50% reduction from Baseline.  The duration of PASI-50 for subjects who end 
treatment with PASI score at least 50% less than Baseline will be censored at the last 
disease assessment date.
Duration of PASI-75, defined analogously to duration of PASI-50 
Percent change from baseline in PASI score at each disease assessment
Shift from the baseline IGA score to the last reported IGA score on study
Frequency of disease recurrence among subjects who stop therapy due to disease 
clearance. Disease recurrence is defined as any instance where IGA is 
2 or mPASI is 
greater than 0.
Time to disease recurrence among subjects who stop therapy due to disease clearance.  
Time to disease recurrence is defined as the time from the last dose of ARQ-151 to the 


 
 
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first observation of an IGA score of 2 or greater.  The time to disease recurrence among 
subjects with clearance at the end of the study observation period will be censored at the 
last observed disease assessment
The incidence of disease control among subjects who restart therapy after having stopped 
therapy due to disease clearance.  Disease control is defined as achieving an IGA score of 
0 or 1 subsequent to restarting study therapy.  
Time to disease control among subjects who restart therapy after having stopped therapy 
due to disease clearance. Time to disease control is the time from the restart of therapy to 
the first reported IGA score of 0 or 1. The time to disease control among subjects who do 
not achieve an IGA score of 0 or 1 by the end of the study observation period will be 
censored at the last observed disease assessment.
9.
REFERENCES
Berger, RS, Bowman JP. A reappraisal of the 21-day Cumulative Irritation Test in man. J.
Toxicol Ot & Ocular Toxicol 1982:1(2);109-115. 
Brion DE, Raynaud F, Plet A, Laurent P, Leduc B, and Anderson W. Deficiency of cyclic AMP-
dependent protein kinases in human psoriasis. Proc. Natl. Acad. Sci. 1986; 83:5272-5276.  
Hatzelmann A, Morcillo EJ, Lungarella G, Adnot S, Sanjar S, Beume R, et al. The preclinical 
pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for 
chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2010; 23:235–256. 


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10. INDEX OF PLANNED TABLES
Table 14.0.1.1: Summary of Subject Enrollment and Evaluability (Enrolled Subjects: Cohort 
1) ....................................................................................................................................................30
Table 14.0.1.2: Summary of Subject Enrollment and Evaluability (Enrolled Subjects: Cohort 
2) ....................................................................................................................................................31
Table 14.0.1.3: Summary of Subject Enrollment and Evaluability (Enrolled Subjects) ...............32
Table 14.0.2.1: Summary of Subject Completion/Discontinuation (Safety Subjects: Cohort 1 ) .33
Table 14.0.2.2: Summary of Subject Completion/Discontinuation (Safety Subjects: Cohort 2 ) .34
Table 14.0.2.3: Summary of Subject Completion/Discontinuation (Safety Population) ...............35
Table 14.1.1.1.1: Summary of Subject Demographics (Safety Population: Cohort 1) ..................36
Table 14.1.1.1.2: Summary of Subject Demographics (Safety Population: Cohort 2) ..................37
Table 14.1.1.1.3: Summary of Subject Demographics (Safety Population) ..................................38
Table 14.1.2.1.1: Primary Summary of Subject Baseline Characteristics (Safety Population: 
Cohort 1) ........................................................................................................................................39
Table 14.1.2.1.2: Sensitivity Summary of Subject Baseline Characteristics (Safety Population: 
Cohort 1) ........................................................................................................................................42
Table 14.1.2.2: Summary of Subject Baseline Characteristics (Safety Population: Cohort 2) .....45
Table 14.1.2.3: Summary of Subject Baseline Characteristics (Safety Population) ......................48
Table 14.1.3.1: Summary of Concomitant Medications by ATC Level 2 Term and Standard 
Medication Name (Safety Population: Cohort 1) ..........................................................................51
Table 14.1.3.2: Summary of Concomitant Medications by ATC Level 2 Term and Standard 
Medication Name (Safety Population: Cohort 2) ..........................................................................52
Table 14.1.3.3: Summary of Concomitant Medications by ATC Level 2 Term and Standard 
Medication Name (Safety Population)...........................................................................................53
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA) 
(Safety Population: Cohort 1) ........................................................................................................54
Table 14.2.1.1.2: Sensitivity Summary of Investigator Global Assessment (IGA) 
(Safety Population: Cohort 1) ........................................................................................................65
Table 14.2.1.1.3: Summary of Investigator Global Assessment (IGA) (Safety Population: Cohort 
2) ....................................................................................................................................................71
Table 14.2.1.1.4: Summary of Investigator Global Assessment (IGA) (Safety Population) .........77
Table 14.2.1.2.1: Shift Table of Investigator Global Assessment (IGA) (Safety Population: 
Cohort 1) ........................................................................................................................................83


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
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Table 14.2.1.2.2: Sensitivity Shift Table of Investigator Global Assessment (IGA) (Safety 
Population: Cohort 1) .....................................................................................................................84
Table 14.2.1.2.3: Shift Table of Investigator Global Assessment (IGA) (Safety Population: 
Cohort 2) ........................................................................................................................................85
Table 14.2.1.2.4: Shift Table of Investigator Global Assessment (IGA) (Safety Population) ......86
Table 14.2.2.1: Primary Summary of Intrigenous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 1) ........................................................................................................87
Table 14.2.2.2: Sensitivity Summary of Intertriginous Investigator Global Assessment (I-IGA)  
(Safety Population: Cohort 1) ........................................................................................................93
Table 14.2.2.3: Summary of Intertriginous Investigator Global Assessment (I-IGA)  
(Safety Population: Cohort 2) ........................................................................................................96
Table 14.2.2.4: Summary of Intertriginous Investigator Global Assessment (I-IGA)  
(Safety Population) ........................................................................................................................99
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI)  
(Safety Population: Cohort 1) ......................................................................................................102
Table 14.2.3.2: Sensitivity Summary of Psoriasis Area and Severity Index (PASI)  
(Safety Population: Cohort 1) ......................................................................................................109
Table 14.2.3.3: Summary of Psoriasis Area and Severity Index (PASI)  (Safety Population: 
Cohort 2) ......................................................................................................................................115
Table 14.2.3.4: Summary of Psoriasis Area and Severity Index (PASI)  (Safety Population) ....121
Table 14.2.4.1: Primary Summary of Modified Psoriasis and Severity Index (mPASI)  
(Safety Population: Cohort 1) ......................................................................................................127
Table 14.2.4.2: Sensitivity Summary of Modified Psoriasis and Severity Index (mPASI)  
(Safety Population: Cohort 1) ......................................................................................................133
Table 14.2.4.3: Summary of Modified Psoriasis and Severity Index (mPASI)  (Safety Population: 
Cohort 2) ......................................................................................................................................138
Table 14.2.4.4: Summary of Modified Psoriasis and Severity Index (mPASI)  
(Safety Population) ......................................................................................................................143
Table 14.2.5.1: Summary of Duration of Treatment Free Interval and Investigator Global 
Assessment (IGA) Success (Safety Population: Cohort 1) ..........................................................149
Figure 14.2.5.1.1:  Kaplan-Meier Plot of Treatment Free Interval (Weeks) (Safety Population: 
Cohort 1) ......................................................................................................................................150
Figure 14.2.5.1.2:  Kaplan-Meier Plot of Duration of Investigator Global Assessment (IGA) 
Success (Weeks) (Safety Population: Cohort 1) ..........................................................................151
Table 14.2.5.2: Summary of Duration of Treatment Free Interval and Investigator Global 
Assessment (IGA) Success (Safety Population: Cohort 2) ..........................................................152


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
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CONFIDENTIAL
Figure 14.2.5.2.1:  Kaplan-Meier Plot of Treatment Free Interval (Weeks) (Safety Population: 
Cohort 2) ......................................................................................................................................153
Figure 14.2.5.2.2:  Kaplan-Meier Plot of Duration of Investigator Global Assessment (IGA) 
Success (Weeks) (Safety Population: Cohort 2) ..........................................................................154
Table 14.2.5.3: Summary of Duration of Treatment Free Interval and Investigator Global 
Assessment (IGA) Success (Safety Population) ..........................................................................155
Figure 14.2.5.3.1:  Kaplan-Meier Plot of Treatment Free Interval (Weeks) (Safety 
Population) ...................................................................................................................................156
Figure 14.2.5.3.2:  Kaplan-Meier Plot of Duration of Investigator Global Assessment (IGA) 
Success (Weeks) (Safety Population) ..........................................................................................157
Table 14.2.6.1: Summary of Disease Recurrence  (Safety Population: Cohort 1) ......................158
Table 14.2.6.2: Summary of Disease Recurrence  (Safety Population: Cohort 2) ......................159
Table 14.2.6.3: Summary of Disease Recurrence  (Safety Population) .......................................160
Table 14.2.7.1: Summary of Duration of Investigator Global Assessment (IGA) of Clear or 
Almost Clear (Safety Population: Cohort 1) ................................................................................161
Figure 14.2.7.1:  Kaplan-Meier Plot of Duration of Investigator Global Assessment (IGA) of 
Clear or Almost Clear (Weeks) (Safety Population: Cohort 1) ...................................................162
Table 14.2.7.2: Summary of Duration of Investigator Global Assessment (IGA) of Clear or 
Almost Clear (Safety Population: Cohort 2) ................................................................................163
Figure 14.2.7.2:  Kaplan-Meier Plot of Duration of Investigator Global Assessment (IGA) of 
Clear or Almost Clear (Weeks) (Safety Population: Cohort 2) ...................................................164
Table 14.2.7.3: Summary of Duration of Investigator Global Assessment (IGA) of Clear or 
Almost Clear (Safety Population) ................................................................................................165
Figure 14.2.7.3:  Kaplan-Meier Plot of Duration of Investigator Global Assessment (IGA) of 
Clear or Almost Clear (Weeks) (Safety Population) ...................................................................166
Table 14.2.8.1.1: Primary Summary of Duration of PASI-50 (Safety Population: Cohort 1).....167
Figure 14.2.8.1.1: Primary Kaplan-Meier Plot of Duration of PASI-50 (Safety Population: 
Cohort 1) ......................................................................................................................................168
Table 14.2.8.1.2: Sensitivity Summary of Duration of PASI-50 (Safety Population: Cohort 1) 169
Figure 14.2.8.1.2:  Sensitivity Kaplan-Meier Plot of Duration of PASI-50 (Safety Population: 
Cohort 1) ......................................................................................................................................170
Table 14.2.8.2: Summary of Duration of PASI-50 (Safety Population: Cohort 2) .....................171
Figure 14.2.8.2:  Kaplan-Meier Plot of Duration of PASI-50 (Safety Population: Cohort 2) .....172
Table 14.2.8.3: Summary of Duration of PASI-50 (Safety Population) ......................................173
Figure 14.2.8.3:  Kaplan-Meier Plot of Duration of PASI-50 (Safety Population) .....................174


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
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Table 14.2.9.1: Summary of Duration of PASI-75 (Safety Population: Cohort 1) .....................175
Figure 14.2.9.1:  Kaplan-Meier Plot of Duration of PASI-75 (Safety Population: Cohort 1) .....176
Table 14.2.9.2: Summary of Duration of PASI-75 (Safety Population: Cohort 2) .....................177
Figure 14.2.9.2:  Kaplan-Meier Plot of Duration of PASI-75 (Safety Population: Cohort 2) .....178
Table 14.2.9.3: Summary of Duration of PASI-75 (Safety Population) ......................................179
Figure 14.2.9.3:  Kaplan-Meier Plot of Duration of PASI-75 (Safety Population) .....................180
Table 14.2.10.1: Summary of Time to Disease Recurrence (Safety Population: Cohort 1) ........181
Figure 14.2.10.1:  Kaplan-Meier Plot of Time to Disease Recurrence (Safety Population: Cohort 
1) ..................................................................................................................................................182
Table 14.2.10.2: Summary of Time to Disease Recurrence (Safety Population: Cohort 2) ........183
Figure 14.2.10.2:  Kaplan-Meier Plot of Time to Disease Recurrence (Safety Population: Cohort 
2) ..................................................................................................................................................184
Table 14.2.10.3: Summary of Time to Disease Recurrence (Safety Population) ........................185
Figure 14.2.10.3:  Kaplan-Meier Plot of Time to Disease Recurrence (Safety Population) .......186
Table 14.2.11.1: Summary of Disease Control (Safety Population: Cohort 1) ...........................187
Figure 14.2.11.1:  Kaplan-Meier Plot of Time to Disease Control (Safety Population: Cohort 
1) ..................................................................................................................................................188
Table 14.2.11.2: Summary of Disease Control (Safety Population: Cohort 2) ...........................189
Figure 14.2.11.2:  Kaplan-Meier Plot of Time to Disease Control (Safety Population: Cohort 
2) ..................................................................................................................................................190
Table 14.2.11.3: Summary of Disease Control (Safety Population) ............................................191
Figure 14.2.11.3:  Kaplan-Meier Plot of Time to Disease Control (Safety Population) .............192
Table 14.3.0.1.1: Summary of Extent of Exposure (Safety Population: Cohort 1) .....................193
Table 14.3.0.1.2: Summary of Extent of Exposure (Safety Population: Cohort 2) .....................194
Table 14.3.0.1.3: Summary of Extent of Exposure (Safety Population) .....................................195
Table 14.3.1.1.1: Summary of Local Tolerability (Safety Population: Cohort 1) .......................196
Table 14.3.1.1.2: Summary of Local Tolerability (Safety Population: Cohort 2) .......................199
Table 14.3.1.1.3: Summary of Local Tolerability (Safety Population) .......................................202
Table 14.3.1.2.1: Summary of Patient Health Questionnaire Depression Scale Assessments 
(PHQ-8) (Safety Population: Cohort 1) .......................................................................................205
Table 14.3.1.2.2: Summary of Patient Health Questionnaire Depression Scale Assessments 
(PHQ-8) (Safety Population: Cohort 2) .......................................................................................207


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
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Table 14.3.1.2.3: Summary of Patient Health Questionnaire Depression Scale Assessments 
(PHQ-8) (Safety Population) .......................................................................................................209
Table 14.3.1.3.1: Shift Summary of Patient Health Questionnaire Depression Scale Assessments 
(PHQ-8) by Treatment Group  (Safety Population: Cohort 1) ....................................................211
Table 14.3.1.3.2: Shift Summary of Patient Health Questionnaire Depression Scale Assessments 
(PHQ-8) by Treatment Group  (Safety Population: Cohort 2) ....................................................213
Table 14.3.1.3.3: Shift Summary of Patient Health Questionnaire Depression Scale Assessments 
(PHQ-8) by Treatment Group  (Safety Population) .....................................................................215
Table 14.3.1.4.1.1: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-
Inurious Behavior without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale 
(C-SSRS) During Treatment (Safety Population: Cohort 1) .......................................................217
Table 14.3.1.4.1.2: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-
Inurious Behavior without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale 
(C-SSRS) During Treatment (Safety Population: Cohort 1) .......................................................218
Table 14.3.1.4.1.3: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-
Inurious Behavior without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale 
(C-SSRS) During Treatment (Safety Population)........................................................................219
Table 14.3.1.4.2.1: Number of Patients with Suicidal-Related Treatment-Emergent Events Based 
on the Columbia-Suicide Severity Rating Scale (C-SSRS) During Treatment (Safety Population: 
Cohort 1) ......................................................................................................................................220
Table 14.3.1.4.2.2: Number of Patients with Suicidal-Related Treatment-Emergent Events Based 
on the Columbia-Suicide Severity Rating Scale (C-SSRS) During Treatment (Safety Population: 
Cohort 2) ......................................................................................................................................221
Table 14.3.1.4.2.3: Number of Patients with Suicidal-Related Treatment-Emergent Events Based 
on the Columbia-Suicide Severity Rating Scale (C-SSRS) During Treatment (Safety 
Population) ...................................................................................................................................222
Table 14.3.2.1.1.1: Summary of Treatment-Emergent Adverse Event Characteristics (Safety 
Population: Cohort 1) ...................................................................................................................223
Table 14.3.2.1.1.2: Summary of Post Active Treatment-Emergent Adverse Events Characteristics 
(Safety Population: Cohort 1) ......................................................................................................224
Table 14.3.2.1.2: Summary of Treatment-Emergent Adverse Event Characteristics (Safety 
Population: Cohort 2) ...................................................................................................................225
Table 14.3.2.1.3.1: Summary of Treatment-Emergent Adverse Event Characteristics  (Safety 
Population) ...................................................................................................................................226
Table 14.3.2.1.3.2: Summary of Post Active Treatment-Emergent Adverse Events Characteristics 
(Safety Population) ......................................................................................................................227


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
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   Page 26 of 337 
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Table 14.3.2.2.1.1: Summary of Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Safety Population: Cohort 1) .................................................228
Table 14.3.2.2.1.2: Summary of Post Active Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term (Safety Population: Cohort 1) ....................................229
Table 14.3.2.2.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Safety Population: Cohort 2) ............................................................230
Table 14.3.2.2.3.1: Summary of Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term (Safety Population) .................................................................231
Table 14.3.2.2.3.2: Summary of Post Active Treatment-Emergent Adverse Events System Organ 
Class and Preferred Term (Safety Population) ............................................................................232
Table 14.3.2.3.1.1: Summary of Treatment-Emergent Adverse Events by Severity (Safety 
Population: Cohort 1) ...................................................................................................................233
Table 14.3.2.3.1.2: Summary of Post Active Treatment-Emergent Adverse Events by Severity 
(Safety Population: Cohort 1) ......................................................................................................234
Table 14.3.2.3.2: Summary of Treatment-Emergent Adverse Events by Severity (Safety 
Population: Cohort 2) ...................................................................................................................235
Table 14.3.2.3.3.1: Summary of Treatment-Emergent Adverse Events by Severity (Safety 
Population) ...................................................................................................................................236
Table 14.3.2.3.3.2: Summary of Post Active Treatment-Emergent Adverse Events by Severity 
(Safety Population) ......................................................................................................................237
Table 14.3.2.4.1.1: Summary of Treatment-Emergent Adverse Events by Relationship (Safety 
Population: Cohort 1) ...................................................................................................................238
Table 14.3.2.4.1.2: Summary of Post Active Treatment-Emergent Adverse Events by 
Relationship (Safety Population: Cohort 1) .................................................................................239
Table 14.3.2.4.2: Summary of Treatment-Emergent Adverse Events by Relationship (Safety 
Population: Cohort 2) ...................................................................................................................240
Table 14.3.2.4.3.1: Summary of Treatment-Emergent Adverse Events by Relationship (Safety 
Population) ...................................................................................................................................241
Table 14.3.2.4.3.2: Summary of Post Active Treatment-Emergent Adverse Events by 
Relationship (Safety Population) .................................................................................................242
Table 14.3.2.5.1.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
(Safety Population: Cohort 1) ......................................................................................................243
Table 14.3.2.5.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events 
Characteristics (Safety Population: Cohort 1) .............................................................................244
Table 14.3.2.5.2: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
(Safety Population: Cohort 2) ......................................................................................................245


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
TOOL.ST.101-01.02 Statistical Analysis Plan Template          
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CONFIDENTIAL
Table 14.3.2.5.3.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
(Safety Population) ......................................................................................................................246
Table 14.3.2.5.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events 
Characteristics (Safety Population) ..............................................................................................247
Table 14.3.2.6.1.1: Summary of Treatment-Emergent Serious Adverse Events by MedDRA 
System Organ Class and Preferred Term (Safety Population: Cohort 1) ....................................248
Table 14.3.2.6.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by 
MedDRA System Organ Class and Preferred Term (Safety Population: Cohort 1) ....................249
Table 14.3.2.6.2: Summary of Treatment-Emergent Serious Adverse Events by MedDRA 
System Organ Class and Preferred Term (Safety Population: Cohort 2) ....................................250
Table 14.3.2.6.3.1: Summary of Treatment-Emergent Serious Adverse Events by MedDRA 
System Organ Class and Preferred Term (Safety Population) .....................................................251
Table 14.3.2.6.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by 
MedDRA System Organ Class and Preferred Term (Safety Population) ....................................252
Table 14.3.2.7.1.1: Summary of Treatment-Emergent Serious Adverse Events by Severity 
(Safety Population: Cohort 1) ......................................................................................................253
Table 14.3.2.7.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by 
Severity (Safety Population: Cohort 1) ........................................................................................254
Table 14.3.2.7.2: Summary of Treatment-Emergent Serious Adverse Events by Severity (Safety 
Population: Cohort 2) ...................................................................................................................255
Table 14.3.2.7.3.1: Summary of Treatment-Emergent Serious Adverse Events by Severity 
(Safety Population) ......................................................................................................................256
Table 14.3.2.7.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by 
Severity (Safety Population) ........................................................................................................257
Table 14.3.2.8.1.1: Summary of Treatment-Emergent Serious Adverse Events by Relationship 
(Safety Population: Cohort 1) ......................................................................................................258
Table 14.3.2.8.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by 
Relationship (Safety Population: Cohort 1) .................................................................................259
Table 14.3.2.8.2: Summary of Treatment-Emergent Serious Adverse Events by Relationship 
(Safety Population: Cohort 2) ......................................................................................................260
Table 14.3.2.8.3.1: Summary of Treatment-Emergent Serious Adverse Events by Relationship 
(Safety Population) ......................................................................................................................261
Table 14.3.2.8.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by 
Relationship (Safety Subjects) .....................................................................................................262
Table 14.3.3.1.1.1: Summary of Chemistry Laboratory Results  (Safety Population: Cohort 
1) ..................................................................................................................................................263


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
TOOL.ST.101-01.02 Statistical Analysis Plan Template          
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CONFIDENTIAL
Table 14.3.3.1.2.1: Summary of Hematology Laboratory Results (Safety Population: Cohort 
1) ..................................................................................................................................................266
Table 14.3.3.1.3.1: Summary of Urinalysis Laboratory Results (Safety Population: Cohort 1) .266
Table 14.3.3.1.1.2: Summary of Chemistry Laboratory Results  (Safety Population: Cohort 
2) ..................................................................................................................................................267
Table 14.3.3.1.2.2: Summary of Hematology Laboratory Results (Safety Population: Cohort 
2) ..................................................................................................................................................270
Table 14.3.3.1.3.2: Summary of Urinalysis Laboratory Results (Safety Population: Cohort 2) .270
Table 14.3.3.1.1.3: Summary of Chemistry Laboratory Results  (Safety Population) ...............271
Table 14.3.3.1.2.3: Summary of Hematology Laboratory Results (Safety Population) ..............274
Table 14.3.3.1.3.3: Summary of Urinalysis Laboratory Results (Safety Population) .................274
Table 14.3.3.2.1.1: Shift Summary of Chemistry Lab Results  (Safety Population: Cohort 1) ...275
Table 14.3.3.2.2.1: Shift Summary of Hematology Laboratory Results (Safety Population: 
Cohort 1) ......................................................................................................................................275
Table 14.3.3.2.3.1: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety 
Population: Cohort 1) ...................................................................................................................275
Table 14.3.3.2.1.2: Shift Summary of Chemistry Lab Results  (Safety Population: Cohort 2) ...276
Table 14.3.3.2.2.2: Shift Summary of Hematology Laboratory Results (Safety Population: 
Cohort 2) ......................................................................................................................................276
Table 14.3.3.2.3.2: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety 
Population: Cohort 2) ...................................................................................................................276
Table 14.3.3.2.1.3: Shift Summary of Chemistry Lab Results  (Safety Population) ...................277
Table 14.3.3.2.2.3: Shift Summary of Hematology Laboratory Results (Safety Population) .....277
Table 14.3.3.2.3.3: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety 
Population) ...................................................................................................................................277
Table 14.3.4.1: Summary of Electrocardiogram (ECG) Parameters (Safety Population: Cohort 
1) ..................................................................................................................................................278
Table 14.3.4.2: Summary of Electrocardiogram (ECG) Parameters (Safety Population: Cohort 
2) ..................................................................................................................................................280
Table 14.3.4.3: Summary of Electrocardiogram (ECG) Parameters (Safety Population) ...........282
Table 14.3.5.1.1: Summary of Vital Signs (Safety Population: Cohort 1) ..................................284
Table 14.3.5.1.2: Summary of Vital Signs (Safety Population: Cohort 2) ..................................287
Table 14.3.5.1.3: Summary of Vital Signs (Safety Population) ..................................................290


Statistical Analysis Plan
Arcutis Biotherapeutics, Inc. ARQ-151-202
Version: 1 
Date: 22OCT2020
TOOL.ST.101-01.02 Statistical Analysis Plan Template          
   Page 29 of 337 
CONFIDENTIAL
Table 14.3.5.2.1: Summary of Change in Body Weight Compared to Baseline 
(Safety Population: Cohort 1) ......................................................................................................293
Table 14.3.5.2.2: Summary of Change in Body Weight Compared to Baseline 
(Safety Population: Cohort 2) ......................................................................................................295
Table 14.3.5.2.3: Summary of Change in Body Weight Compared to Baseline 
(Safety Population) ......................................................................................................................297
Table 14.3.5.3.1: Shift Summary of Body Mass Index (BMI) Results  (Safety Population: Cohort 
1) ..................................................................................................................................................299
Table 14.3.5.3.2: Shift Summary of Body Mass Index (BMI) Results  (Safety Population: Cohort 
2) ..................................................................................................................................................300
Table 14.3.5.3.3: Shift Summary of Body Mass Index (BMI) Results  (Safety Population) ......301


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CONFIDENTIAL
Table 14.0.1.1: Summary of Subject Enrollment and Evaluability
(Enrolled Subjects: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.15%
ARQ-151-201:
Vehicle Cream
Total
Number of Subjects Enrolled
xx
xx
xx
xx
Number of Subjects Excluded from the 
Safety Population
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of Subjects Included in the Safety 
Population
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.0.1.2: Summary of Subject Enrollment and Evaluability
(Enrolled Subjects: Cohort 2)
Roflumilast Cream 0.3%
Number of Subjects Enrolled
xx
Number of Subjects Excluded from the 
Safety Population
xx ( xx.x%)
Number of Subjects Included in the Safety 
Population
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Page 32 of 337
CONFIDENTIAL
Table 14.0.1.3: Summary of Subject Enrollment and Evaluability
(Enrolled Subjects)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
Number of Subjects Enrolled
xx
xx
xx
Number of Subjects Excluded from the 
Safety Population
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of Subjects Included in the Safety 
Population
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.0.2.1: Summary of Subject Completion/Discontinuation
(Safety Subjects: Cohort 1 ) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Completed Study
Yes
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
No
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Reason for Discontinuation
Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost to Follow-Up
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Pregnancy
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Protocol Deviation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Withdrawal by Subject
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Study Terminated by Sponsor
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Physician Decision
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lack of Efficacy
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Othera
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Duration of Participation (Weeks)b
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a See Listing 16.2.1.2 for other discontinuation reasons.  
b Duration of participation (weeks) is defined as (last contact date – date of first dose in ARQ-151-202 + 1) / 7
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.0.2.2: Summary of Subject Completion/Discontinuation
(Safety Subjects: Cohort 2 ) 
Roflumilast Cream 0.3%
(N=xx)
Completed Study
Yes
xx ( xx.x%)
No
xx ( xx.x%)
Reason for Discontinuation
Adverse Event
xx ( xx.x%)
Lost to Follow-Up
xx ( xx.x%)
Pregnancy
xx ( xx.x%)
Protocol Deviation
xx ( xx.x%)
Withdrawal by Subject
xx ( xx.x%)
Study Terminated by Sponsor
xx ( xx.x%)
Physician Decision
xx ( xx.x%)
Lack of Efficacy
xx ( xx.x%)
Othera
xx ( xx.x%)
Duration of Participation (Weeks)b
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
a See Listing 16.2.1.2 for other discontinuation reasons.
b Duration of participation (weeks) is defined as (last contact date – date of first dose + 1) / 7
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.0.2.3: Summary of Subject Completion/Discontinuation
(Safety Population) 
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Completed Study
Yes
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
No
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Reason for Discontinuation
Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost to Follow-Up
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Pregnancy
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Protocol Deviation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Withdrawal by Subject
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Study Terminated by Sponsor
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Physician Decision
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lack of Efficacy
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Othera
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Duration of Participation (Weeks)b
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
a See Listing 16.2.1.2 for other discontinuation reasons.
b Duration of participation (weeks) is defined as (last contact date – date of first dose in ARQ-151-202 + 1) / 7
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.1.1.1: Summary of Subject Demographics
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Age (years)
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Sex
n
xx
xx
xx
xx
Male
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Female
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Ethnicity
n
xx
xx
xx
xx
Hispanic or Latino
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Not Hispanic or Latino
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Race
n
xx
xx
xx
xx
American Indian or Alaska Native
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Asian
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Black or African American
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Native Hawaiian or Other Pacific Islander
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
White
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Multiple/Othera
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a See Listing 16.2.4.1 for a complete list of all other races.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.1.1.2: Summary of Subject Demographics
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Age (years)
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Sex
n
xx
Male
xx ( xx.x%)
Female
xx ( xx.x%)
Ethnicity
n
xx
Hispanic or Latino
xx ( xx.x%)
Not Hispanic or Latino
xx ( xx.x%)
Race
n
xx
American Indian or Alaska Native
xx ( xx.x%)
Asian
xx ( xx.x%)
Black or African American
xx ( xx.x%)
Native Hawaiian or Other Pacific Islander
xx ( xx.x%)
White
xx ( xx.x%)
Multiple/Othera
xx ( xx.x%)
a See Listing 16.2.4.1 for a complete list of all other races.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.1.1.3: Summary of Subject Demographics
(Safety Population)
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Age (years)
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Sex
n
xx
xx
xx
Male
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Female
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Ethnicity
n
xx
xx
xx
Hispanic or Latino
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Not Hispanic or Latino
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Race
n
xx
xx
xx
American Indian or Alaska Native
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Asian
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Black or African American
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Native Hawaiian or Other Pacific Islander
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
White
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Multiple/Othera
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a See Listing 16.2.4.1 for a complete list of all other races.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.1.1: Primary Summary of Subject Baseline Characteristics
(Safety Population: Cohort 1)
(Page 1 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Investigator Global Assessment
n
xx
xx
xx
xx
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Intertriginous Investigator Global 
Assessment a
n
xx
xx
xx
xx
1 - Almost Clear 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Body Surface Area (%) Affected 
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.1.2.1.1: Primary Summary of Subject Baseline Characteristics
(Safety Population: Cohort 1)
(Page 2 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Psoriasis Area Severity Index
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Modified Psoriasis Area Severity Index
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Duration of Psoriasis (Years)
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.1.1: Primary Summary of Subject Baseline Characteristics
(Safety Population: Cohort 1)
(Page 3 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Height (cm)
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Weight (kg)
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.  
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.1.2: Sensitivity Summary of Subject Baseline Characteristics
(Safety Population: Cohort 1)
(Page 1 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Investigator Global Assessment
n
xx
xx
xx
xx
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Intertriginous Investigator Global 
Assessment a
n
xx
xx
xx
xx
1 - Almost Clear 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Body Surface Area (%) Affected 
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
Note:  Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.1.2.1: Summary of Subject Baseline Characteristics
(Safety Population: Cohort 1)
(Page 2 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Psoriasis Area Severity Index
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Modified Psoriasis Area Severity Index
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Duration of Psoriasis (Years)
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
Note: Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.1.2: Sensitivity Summary of Subject Baseline Characteristics
(Safety Population: Cohort 1)
(Page 3 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Height (cm)
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Weight (kg)
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.  
Note:  Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.2: Summary of Subject Baseline Characteristics
(Safety Population: Cohort 2)
(Page 1 of 3) 
Roflumilast Cream 0.3%
(N=xx)
Investigator Global Assessment
n
xx
0 - Clear
xx ( xx.x%)
1 - Almost Clear 
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
Intertriginous Investigator Global 
Assessment a
n
xx
1 - Almost Clear 
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
Body Surface Area (%) Affected 
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.1.2.2: Summary of Subject Baseline Characteristics
(Safety Population: Cohort 2)
(Page 2 of 3) 
Roflumilast Cream 0.3%
(N=xx)
Psoriasis Area Severity Index
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Modified Psoriasis Area Sevierty Index
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Duration of Psoriasis (Years)
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.1.2.2: Summary of Subject Baseline Characteristics
(Safety Population: Cohort 2)
(Page 3 of 3) 
Roflumilast Cream 0.3%
(N=xx)
Height (cm)
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Weight (kg)
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.3: Summary of Subject Baseline Characteristics
(Safety Population)
(Page 1 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Investigator Global Assessment
n
xx
xx
xx
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Intertriginous Investigator Global Assessment a
n
xx
xx
xx
1 - Almost Clear 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Body Surface Area (%) Affected 
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
Note:  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.3: Summary of Subject Baseline Characteristics
(Safety Population)
(Page 2 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Psoriasis Area Severity Index
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Modified Psoriasis Area Severity Index
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Duration of Psoriasis (Years)
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
Note:  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.2.3: Summary of Subject Baseline Characteristics
(Safety Population)
(Page 3 of 3) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Height (cm)
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Weight (kg)
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
a Collected for subjects with intertriginous involvement. Subjects reporting Clear or no intertriginous area involvement are included in denominator for
percentages.
Note:  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.3.1: Summary of Concomitant Medications by ATC Level 2 Term and Standard Medication Name
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
ATC Level 2 Terma
Standard Medication Name
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ATC Level 2 Term
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Standard Medication Name
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more concomitant medications that map to the WHO Drug Dictionary. At each level of summarization
(ATC Level 2 Term or Standard Medication Name) subjects are counted once.  
Note: WHO Drug Dictionary (Version xx).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.1.3.2: Summary of Concomitant Medications by ATC Level 2 Term and Standard Medication Name
(Safety Population: Cohort 2)
(Page 1 of xx)
ATC Level 2 Terma
Standard Medication Name
Roflumilast Cream 0.3%
(N=xx)
ATC Level 2 Term
xx ( xx.x%)
Standard Medication Name
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more concomitant medications that map to the WHO Drug Dictionary. At each level of summarization
(ATC Level 2 Term or Standard Medication Name) subjects are counted once.  
Note: WHO Drug Dictionary (Version xx).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.1.3.3: Summary of Concomitant Medications by ATC Level 2 Term and Standard Medication Name
(Safety Population)
(Page 1 of xx)
 
ARQ-151-202: Roflumilast Cream 0.3%
ATC Level 2 Terma
Standard Medication Name
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
ATC Level 2 Term
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Standard Medication Name
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more concomitant medications that map to the WHO Drug Dictionary. At each level of summarization
(ATC Level 2 Term or Standard Medication Name) subjects are counted once.  
Note: WHO Drug Dictionary (Version xx).  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1) 
(Page 1 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 2 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 2
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 3 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 4
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 4 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 6
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 5 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 8
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 6 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 12
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 7 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 8 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 9 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 63 of 337
CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 10 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.1: Primary Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 11 of 11) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.2: Sensitivity Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 1 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.2: Sensitivity Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 2 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.1.1.2: Sensitivity Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 3 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 68 of 337
CONFIDENTIAL
Table 14.2.1.1.2: Sensitivity Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 4 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 69 of 337
CONFIDENTIAL
Table 14.2.1.1.2: Sensitivity Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 5 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 70 of 337
CONFIDENTIAL
Table 14.2.1.1.2: Sensitivity Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1)
(Page 6 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 71 of 337
CONFIDENTIAL
Table 14.2.1.1.3: Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 2) 
(Page 1 of 6) 
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3% 
(N=xx)
Baseline
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 72 of 337
CONFIDENTIAL
Table 14.2.1.1.3: Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 2) 
(Page 2 of 6) 
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3% 
(N=xx)
Week 4
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 73 of 337
CONFIDENTIAL
Table 14.2.1.1.3: Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 2) 
(Page 3 of 6) 
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3% 
(N=xx)
Week 12
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 74 of 337
CONFIDENTIAL
Table 14.2.1.1.3: Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 2) 
(Page 4 of 6) 
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3% 
(N=xx)
Week 24
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 75 of 337
CONFIDENTIAL
Table 14.2.1.1.3: Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 2) 
(Page 5 of 6) 
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3% 
(N=xx)
Week 36
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 76 of 337
CONFIDENTIAL
Table 14.2.1.1.3: Summary of Investigator Global Assessment (IGA)
(Safety Population: Cohort 2) 
(Page 6 of 6) 
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream 0.3% 
(N=xx)
Week 52
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 77 of 337
CONFIDENTIAL
Table 14.2.1.1.4: Summary of Investigator Global Assessment (IGA)
(Safety Population)
(Page 1 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 78 of 337
CONFIDENTIAL
Table 14.2.1.1.4: Summary of Investigator Global Assessment (IGA)
(Safety Population)
(Page 2 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 79 of 337
CONFIDENTIAL
Table 14.2.1.1.4: Summary of Investigator Global Assessment (IGA)
(Safety Population)
(Page 3 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.1.1.4: Summary of Investigator Global Assessment (IGA)
(Safety Population)
(Page 4 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.1.1.4: Summary of Investigator Global Assessment (IGA)
(Safety Population)
(Page 5 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.1.1.4: Summary of Investigator Global Assessment (IGA)
(Safety Population)
(Page 6 of 6) 
 
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Global Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear Plus 
2-Grade Improvement from Baseline
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.2.1.2.1: Shift Table of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1) 
ARQ-151-201:
Roflumilast Cream 0.3% (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
ARQ-151-201:
Roflumilast Cream 0.15% (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
ARQ-151-201:
Vehicle Cream (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Total (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.1.2.2: Sensitivity Shift Table of Investigator Global Assessment (IGA)
(Safety Population: Cohort 1) 
ARQ-151-201:
Roflumilast Cream 0.3% (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
ARQ-151-201:
Roflumilast Cream 0.15% (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
ARQ-151-201:
Vehicle Cream (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Total (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to entry in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.1.2.3: Shift Table of Investigator Global Assessment (IGA)
(Safety Population: Cohort 2) 
Roflumilast Cream 0.3% (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.1.2.4: Shift Table of Investigator Global Assessment (IGA)
(Safety Population)
ARQ-151-201:
Roflumilast Cream (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
ARQ-151-201: Vehicle Cream
and Cohort 2 (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Total (N=xx)
Last Reported IGA
Baseline IGA
0 - Clear 
1 - Almost Clear 
2 - Mild 
3 - Moderate 
4 - Severe 
0 - Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - Almost Clear
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - Mild
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - Moderate
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - Severe
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.1: Primary Summary of Intrigenous Investigator Global Assessment (I-IGA)
(Safety Population: Cohort 1) 
(Page 1 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
ARQ-151-201 Week 2
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.2.1: Primary Summary of Intrigenous Investigator Global Assessment (I-IGA)
(Safety Population: Cohort 1)
(Page 2 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 4
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
ARQ-151-201 Week 6
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
  with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.  
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.2.1: Primary Summary of Intrigenous Investigator Global Assessment (I-IGA)
(Safety Population: Cohort 1)
(Page 3 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 8
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
ARQ-151-201 Week 12
n
xx
xx
NA
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
  with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.  
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.2.1: Primary Summary of Intrigenous Investigator Global Assessment (I-IGA)
(Safety Population: Cohort 1)
(Page 4 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 12
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
  with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.  
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.1: Primary Summary of Intrigenous Investigator Global Assessment (I-IGA)
(Safety Population: Cohort 1)
(Page 5 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 36
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
  with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.  
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.1: Primary Summary of Intrigenous Investigator Global Assessment (I-IGA)
(Safety Population: Cohort 1)
(Page 6 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast Cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.  
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.2: Sensitivity Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 1)
(Page 1 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
xx
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 4
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study. Collected for subjects with intertriginous involvement. Subjects 
reporting no intertriginous area involvement are included in denominator for percentages. 
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.2: Sensitivity Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 1)
(Page 2 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 24
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study. Collected for subjects with intertriginous involvement. Subjects 
reporting no intertriginous area involvement are included in denominator for percentages. 
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.2: Sensitivity Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 1)
(Page 3 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 52
n
xx
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study. Collected for subjects with intertriginous involvement. Subjects 
reporting no intertriginous area involvement are included in denominator for percentages. 
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.3: Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 2)
(Page 1 of 3)
Intertriginous Investigator Global 
Assessment
Roflumilast Cream 0.3%
(N=xx)
Baselinea
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Week 4
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
a Collected for subjects with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.3: Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 2) 
(Page 2 of 3)
Intertriginous Investigator Global 
Assessment
Roflumilast Cream 0.3%
(N=xx)
Week 12
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
Week 24
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
a Collected for subjects with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.3: Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 2) 
(Page 3 of 3)
Intertriginous Investigator Global 
Assessment
Roflumilast Cream 0.3%
(N=xx)
Week 36
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
Week 52
n
xx
0 - Clear
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
2 - Mild
xx (
xx%)
3 - Moderate
xx (
xx%)
4 - Severe
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
Failure
xx (
xx%)
a Collected for subjects with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages.
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.2.4: Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population) 
(Page 1 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 4
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages. 
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.2.4: Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population: Cohort 1)
(Page 2 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 24
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages. 
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.2.4: Summary of Intertriginous Investigator Global Assessment (I-IGA) 
(Safety Population) 
(Page 3 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Intertriginous Investigator Global 
Assessment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
Week 52
n
xx
xx
xx
0 - Clear
xx (
xx%)
xx (
xx%)
xx (
xx%)
1 - Almost Clear 
xx (
xx%)
xx (
xx%)
xx (
xx%)
2 - Mild
xx (
xx%)
xx (
xx%)
xx (
xx%)
3 - Moderate
xx (
xx%)
xx (
xx%)
xx (
xx%)
4 - Severe
xx (
xx%)
xx (
xx%)
xx (
xx%)
Score of Clear or Almost Clear
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. Collected for subjects 
with intertriginous involvement. Subjects reporting no intertriginous area involvement are included in denominator for percentages. 
Note: Collected post-baseline for subjects with a severity of at least mild. No imputation of missing values. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI) 
(Safety Population: Cohort 1)
(Page 1 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 103 of 337
CONFIDENTIAL
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 2 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 2
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 104 of 337
CONFIDENTIAL
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 3 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 4
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 105 of 337
CONFIDENTIAL
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 4 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 6
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 106 of 337
CONFIDENTIAL
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 5 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 8
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 107 of 337
CONFIDENTIAL
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 6 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 12
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 108 of 337
CONFIDENTIAL
Table 14.2.3.1: Primary Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 7 of 11)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to the programmer:Repeat this page for Week 12, 24, 36 and 52.


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 109 of 337
CONFIDENTIAL
Table 14.2.3.2: Sensitivity Summary of Psoriasis Area and Severity Index (PASI) 
(Safety Population: Cohort 1)
(Page 1 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 110 of 337
CONFIDENTIAL
Table 14.2.3.2: Sensitivity Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 2 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 111 of 337
CONFIDENTIAL
Table 14.2.3.2: Sensitivity Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 3 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 112 of 337
CONFIDENTIAL
Table 14.2.3.2: Sensitivity Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 4 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 113 of 337
CONFIDENTIAL
Table 14.2.3.2: Sensitivity Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 5 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 114 of 337
CONFIDENTIAL
Table 14.2.3.2: Sensitivity Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 1)
(Page 6 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.2.3.3: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 2)
(Page 1 of 6)
Psoriasis Area and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Baseline
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.3.3: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 2)
(Page 2 of 6) 
Psoriasis Area and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 4
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
PASI-50
Success
xx (
xx%)
Failure
xx (
xx%)
PASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.3.3: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 2)
(Page 3 of 6) 
Psoriasis Area and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 12
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
PASI-50
Success
xx (
xx%)
Failure
xx (
xx%)
PASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.3.3: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 2)
(Page 4 of 6) 
Psoriasis Area and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 24
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
PASI-50
Success
xx (
xx%)
Failure
xx (
xx%)
PASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.3.3: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 2)
(Page 5 of 6) 
Psoriasis Area and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 36
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
PASI-50
Success
xx (
xx%)
Failure
xx (
xx%)
PASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 120 of 337
CONFIDENTIAL
Table 14.2.3.3: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population: Cohort 2)
(Page 6 of 6) 
Psoriasis Area and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 52
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
PASI-50
Success
xx (
xx%)
Failure
xx (
xx%)
PASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 121 of 337
CONFIDENTIAL
Table 14.2.3.4: Summary of Psoriasis Area and Severity Index (PASI) 
(Safety Population)
(Page 1 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 122 of 337
CONFIDENTIAL
Table 14.2.3.4: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population)
(Page 2 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 123 of 337
CONFIDENTIAL
Table 14.2.3.4: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population)
(Page 3 of 6)
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 124 of 337
CONFIDENTIAL
Table 14.2.3.4: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population)
(Page 4 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 125 of 337
CONFIDENTIAL
Table 14.2.3.4: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population)
(Page 5 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 126 of 337
CONFIDENTIAL
Table 14.2.3.4: Summary of Psoriasis Area and Severity Index (PASI)
(Safety Population)
(Page 6 of 6) 
ARQ-151-202: Roflumilast Cream 0.3%
Psoriasis Area and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
PASI-50
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
PASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. PASI-50 is defined as a 50% reduction from baseline of PASI. PASI-75 is defined as a 75% reduction from Baseline of 
PASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 127 of 337
CONFIDENTIAL
Table 14.2.4.1: Primary Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 1 of 10)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
ARQ-151-201 Week 2
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 128 of 337
CONFIDENTIAL
Table 14.2.4.1: Primary Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 2 of 10)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 4
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 129 of 337
CONFIDENTIAL
Table 14.2.4.1: Primary Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 3 of 10)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 6
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 130 of 337
CONFIDENTIAL
Table 14.2.4.1: Primary Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 4 of 10)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 8
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 131 of 337
CONFIDENTIAL
Table 14.2.4.1: Primary Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 5 of 10)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
ARQ-151-201 Week 12
n
xx
xx
NA
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.4.1: Primary Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 6 of 10)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a  Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study. 
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to the programmer:Repeat this page for Week 12, 24, 36 and 52.


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.4.2: Sensitivity Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 1 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 4
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.4.2: Sensitivity Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 2 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.4.2: Sensitivity Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 3 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.4.2: Sensitivity Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 4 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 137 of 337
CONFIDENTIAL
Table 14.2.4.2: Sensitivity Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 1)
(Page 5 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
xx
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
xx
SD
xx.x
xx.x
xx.x
xx.x
Median
xx
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.4.3: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 2)
(Page 1 of 5)
Modified Psoriasis and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Baseline
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Week 4
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
mPASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.2.4.3: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 2)
(Page 2 of 5)
Modified Psoriasis and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 12
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
mPASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 140 of 337
CONFIDENTIAL
Table 14.2.4.3: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 2)
(Page 3 of 5)
Modified Psoriasis and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 24
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
mPASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 141 of 337
CONFIDENTIAL
Table 14.2.4.3: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 2)
(Page 4 of 5)
Modified Psoriasis and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 36
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
mPASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 142 of 337
CONFIDENTIAL
Table 14.2.4.3: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population: Cohort 2)
(Page 5 of 5)
Modified Psoriasis and Severity Index
Roflumilast Cream 0.3%
(N=xx)
Week 52
n
xx
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
Change from Baseline 
Mean
xx
SD
xx.x
Median
xx
Min. to Max
xx to xx
Percent Change from Baseline
Mean
xx
SD
xx.x
Median
xx
Min. to Max.
xx to xx
mPASI-75
Success
xx (
xx%)
Failure
xx (
xx%)
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 143 of 337
CONFIDENTIAL
Table 14.2.4.4: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population)
(Page 1 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baselinea
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.xx
xx.xx
xx.xx
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 144 of 337
CONFIDENTIAL
Table 14.2.4.4: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population)
(Page 2 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 4
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 145 of 337
CONFIDENTIAL
Table 14.2.4.4: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population)
(Page 2 of 5)
 
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
AR Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx.x
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 146 of 337
CONFIDENTIAL
Table 14.2.4.4: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population)
(Page 3 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 147 of 337
CONFIDENTIAL
Table 14.2.4.4: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population)
(Page 4 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 148 of 337
CONFIDENTIAL
Table 14.2.4.4: Summary of Modified Psoriasis and Severity Index (mPASI)
(Safety Population)
(Page 5 of 5)
ARQ-151-202: Roflumilast Cream 0.3%
Modified Psoriasis and Severity Index
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline 
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max
xx to xx
xx to xx
xx to xx
Percent Change from Baseline
Mean
xx
xx
xx
SD
xx.x
xx.x
xx.x
Median
xx
xx
xx
Min. to Max.
xx to xx
xx to xx
xx to xx
mPASI-75
Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Failure
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
Note: No imputation of missing values. mPASI-75 is defined as a 75% reduction from baseline of mPASI.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.2.5.1: Summary of Duration of Treatment Free Interval and Investigator Global Assessment (IGA) Success
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Number of Subjects who Achieved Disease 
Clearance and Stopped Treatment
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Treatment Free Interval (Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
Resumed Treatment
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
    Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Number of Subjects With IGA Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Duration of IGA Success (Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Disease clearance is defined as Clear scores for IGA, I-IGA (if applicable) and mPASI (if applicable). 
Treatment free interval is defined as time to re-starting study drug for subjects who achieved disease clearance and stopped treatment to all lesions. 
Subjects not re-starting study drug before ending participation in the study were censored at the day of the last observed disease assessment. 
IGA success defined as achievement of an IGA of Clear or Almost Clear plus a 2-grade improvement in IGA. Duration of IGA success is defined as the 
time from first observation of IGA success to the first subsequent time a subject’s disease response does not meet the criteria for IGA success. Subjects 
with a continued success at end of participation in the study were censored at the day of the last observed disease assessment. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)






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Table 14.2.5.2: Summary of Duration of Treatment Free Interval and Investigator Global Assessment (IGA) Success
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Number of Subjects who Achieved Disease 
Clearance and Stopped Treatment
xx (
xx%)
Treatment Free Interval (Weeks)
n
xx
Mediana
xx
    Resumed Treatment
xx (
xx%)
    Censored
xx (
xx%)
Number of Subjects With IGA Success
xx (
xx%)
Duration of IGA Success (Weeks)
n
xx
Mediana
xx
  Disease Recurrence
xx (
xx%)
  Censored
xx (
xx%)
a Median determined using the Kaplan-Meier method. 
Note: Disease clearance is defined as Clear scores for IGA, I-IGA (if applicable) and mPASI (if applicable).
Treatment free interval is defined as time to re-starting study drug for subjects who achieved disease clearance and stopped treatment to all lesions. 
Subjects not re-starting study drug before ending participation in the study were censored at the day of the last observed disease assessment. 
IGA success defined as achievement of an IGA of Clear or Almost Clear plus a 2-grade improvement in IGA. Duration of IGA success is defined as the 
time from first observation of IGA success to the first subsequent time a subject’s disease response does not meet the criteria for IGA success. Subjects 
with a continued success at end of participation in the study were censored at the day of the last observed disease assessment.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)






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Table 14.2.5.3: Summary of Duration of Treatment Free Interval and Investigator Global Assessment (IGA) Success
(Safety Population) 
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Number of Subjects who Achieved Disease 
Clearance and Stopped Treatment
xx (
xx%)
xx (
xx%)
xx (
xx%)
Treatment Free Interval (Weeks)
n
xx
xx
xx
Mediana
xx
xx
xx
    Resumed Treatment
xx (
xx%)
xx (
xx%)
xx (
xx%)
    Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
Number of Subjects With IGA Success
xx (
xx%)
xx (
xx%)
xx (
xx%)
Duration of IGA Success (Weeks)
n
xx
xx
xx
Mediana
xx
xx
xx
Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Disease clearance is defined as Clear scores for IGA, I-IGA (if applicable) and mPASI (if applicable).
Treatment free interval is defined as time to re-starting study drug for subjects who achieved disease clearance and stopped treatment to all lesions. 
Subjects not re-starting study drug before ending participation in the study were censored at the day of the last observed disease assessment.
IGA success defined as achievement of an IGA of Clear or Almost Clear plus a 2-grade improvement in IGA. Duration of IGA success is defined as the 
time from first observation of IGA success to the first subsequent time a subject’s disease response does not meet the criteria for IGA success. Subjects 
with a continued success at end of participation in the study were censored at the day of the last observed disease assessment.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)






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Table 14.2.6.1: Summary of Disease Recurrence
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Total Number of Instances of Disease 
Recurrence Following Clearance 
n
xx
xx
xx
xx
0
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4+
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Number of Instances of Disease Recurrence 
Following Clearance Through Week 24a 
n
xx
xx
xx
xx
0
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4+
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Number of Instances of Disease Recurrence 
Following Clearance Through Week 52a 
n
xx
xx
xx
xx
0
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
1
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
2
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
3
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
4+
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Percentages calculated out of total number of subjects who participated in study through the respective visit. 
Note: Disease clearance defined as an IGA of Clear and mPASI of 0.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.2.6.2: Summary of Disease Recurrence
(Safety Population: Cohort 2) 
ARQ-151-201:
Roflumilast Cream 0.3% 
(N=xx)
Total Number of Instances of Disease 
Recurrence Following Clearance
n
xx
0
xx (
xx%)
1
xx (
xx%)
2
xx (
xx%)
3
xx (
xx%)
4+
xx (
xx%)
Number of Instances of Disease Recurrence 
Following Clearance Through Week 24a 
n
xx
0
xx (
xx%)
1
xx (
xx%)
2
xx (
xx%)
3
xx (
xx%)
4+
xx (
xx%)
Number of Instances of Disease Recurrence 
Following Clearance Through Week 52a 
n
xx
0
xx (
xx%)
1
xx (
xx%)
2
xx (
xx%)
3
xx (
xx%)
4+
xx (
xx%)
a Percentages calculated out of total number of subjects who participated in study through the respective visit.
Note: Disease clearance defined as an IGA of Clear and mPASI of 0.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.2.6.3: Summary of Disease Recurrence
(Safety Population)
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Total Number of Instances of Disease 
Recurrence Following Clearance 
n
xx
xx
xx
0
xx (
xx%)
xx (
xx%)
xx (
xx%)
1
xx (
xx%)
xx (
xx%)
xx (
xx%)
2
xx (
xx%)
xx (
xx%)
xx (
xx%)
3
xx (
xx%)
xx (
xx%)
xx (
xx%)
4+
xx (
xx%)
xx (
xx%)
xx (
xx%)
Number of Instances of Disease Recurrence 
Following Clearance Through Week 24a 
n
xx
xx
xx
0
xx (
xx%)
xx (
xx%)
xx (
xx%)
1
xx (
xx%)
xx (
xx%)
xx (
xx%)
2
xx (
xx%)
xx (
xx%)
xx (
xx%)
3
xx (
xx%)
xx (
xx%)
xx (
xx%)
4+
xx (
xx%)
xx (
xx%)
xx (
xx%)
Number of Instances of Disease Recurrence 
Following Clearance Through Week 24a 
n
xx
xx
xx
0
xx (
xx%)
xx (
xx%)
xx (
xx%)
1
xx (
xx%)
xx (
xx%)
xx (
xx%)
2
xx (
xx%)
xx (
xx%)
xx (
xx%)
3
xx (
xx%)
xx (
xx%)
xx (
xx%)
4+
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Percentages calculated out of total number of subjects who participated in study through the respective visit.
Note: Disease clearance defined as an IGA of Clear and mPASI of 0.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.2.7.1: Summary of Duration of Investigator Global Assessment (IGA) of Clear or Almost Clear
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Duration of IGA of Clear or Almost Clear
(Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Duration of IGA of Clear or Almost Clear is defined as the time from the first observation of IGA Clear or Almost Clear to the first subsequent time a 
subject’s IGA is not Clear or Almost Clear. The duration of IGA Clear or Almost Clear for subjects who end treatment with IGA Clear or Almost Clear
will be censored at the last IGA date. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.7.2: Summary of Duration of Investigator Global Assessment (IGA) of Clear or Almost Clear
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Duration of IGA of Clear or Almost Clear 
(Weeks)
n
xx
Mediana
xx
  Disease Recurrence
xx (
xx%)
  Censored
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Duration of IGA of Clear or Almost Clear is defined as the time from the first observation of IGA Clear or Almost Clear to the first subsequent time a 
subject’s IGA is not Clear or Almost Clear. The duration of IGA Clear or Almost Clear for subjects who end treatment with IGA Clear or Almost Clear 
will be censored at the last IGA date.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.7.3: Summary of Duration of Investigator Global Assessment (IGA) of Clear or Almost Clear
(Safety Population) 
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Duration of IGA of Clear or Almost Clear 
(Weeks)
n
xx
xx
xx
Mediana
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method. 
Note: Duration of IGA of Clear or Almost Clear is defined as the time from the first observation of IGA Clear or Almost Clear to the first subsequent time a 
subject’s IGA is not Clear or Almost Clear. The duration of IGA Clear or Almost Clear for subjects who end treatment with IGA Clear or Almost Clear 
will be censored at the last IGA date.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.8.1.1: Primary Summary of Duration of PASI-50
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Duration of PASI-50 (Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Duration of PASI-50 is defined as the time from the first observation of a 50% reduction from baseline in the Psoriasis Area and Severity Index (PASI) 
to the first subsequent time a subjects’s PASI score is greater than a 50% reduction from baseline. The duration of PASI-50 for subjects who end treatment 
with PASI score at least 50% less than baseline will be censored at the last disease assessment date. 
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.8.1.2: Sensitivity Summary of Duration of PASI-50
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Duration of PASI-50 (Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method. 
Note: Duration of PASI-50 is defined as the time from the first observation of a 50% reduction from baseline in the Psoriasis Area and Severity Index (PASI) 
to the first subsequent time a subjects’s PASI score is greater than a 50% reduction from baseline. The duration of PASI-50 for subjects who end treatment 
with PASI score at least 50% less than baseline will be censored at the last disease assessment date.
Baseline is defined as the last observation prior to entrance into the ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.8.2: Summary of Duration of PASI-50
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Duration of PASI-50 (Weeks)
n
xx
Mediana
xx
  Disease Recurrence
xx (
xx%)
  Censored
xx (
xx%)
a Median determined using the Kaplan-Meier method. 
Note: Duration of PASI-50 is defined as the time from the first observation of a 50% reduction from baseline in the Psoriasis Area and Severity Index (PASI) 
to the first subsequent time a subjects’s PASI score is greater than a 50% reduction from baseline. The duration of PASI-50 for subjects who end treatment 
with PASI score at least 50% less than baseline will be censored at the last disease assessment date.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.8.3: Summary of Duration of PASI-50
(Safety Population)
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Duration of PASI-50 (Weeks)
n
xx
xx
xx
Mediana
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Duration of PASI-50 is defined as the time from the first observation of a 50% reduction from baseline in the Psoriasis Area and Severity Index (PASI) 
to the first subsequent time a subjects’s PASI score is greater than a 50% reduction from baseline. The duration of PASI-50 for subjects who end treatment 
with PASI score at least 50% less than baseline will be censored at the last disease assessment date.
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.9.1: Summary of Duration of PASI-75
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Duration of PASI-75 (Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Duration of PASI-75 is defined as the time from the first observation of a 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI) 
to the first subsequent time a subjects’s PASI score is greater than a 75% reduction from baseline. The duration of PASI-75 for subjects who end treatment 
with PASI score at least 75% less than baseline will be censored at the last disease assessment date.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.9.2: Summary of Duration of PASI-75
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Duration of PASI-75 (Weeks)
n
xx
Mediana
xx
  Disease Recurrence
xx (
xx%)
  Censored
xx (
xx%)
a Median determined using the Kaplan-Meier method. 
Note: Duration of PASI-75 is defined as the time from the first observation of a 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI) 
to the first subsequent time a subjects’s PASI score is greater than a 75% reduction from baseline. The duration of PASI-75 for subjects who end treatment 
with PASI score at least 75% less than baseline will be censored at the last disease assessment date.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.9.3: Summary of Duration of PASI-75
(Safety Population)
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Duration of PASI-75 (Weeks)
n
xx
xx
xx
Mediana
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Duration of PASI-75 is defined as the time from the first observation of a 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI) 
to the first subsequent time a subjects’s PASI score is greater than a 75% reduction from baseline. The duration of PASI-75 for subjects who end treatment 
with PASI score at least 75% less than baseline will be censored at the last disease assessment date.
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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Table 14.2.10.1: Summary of Time to Disease Recurrence
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Time to Disease Recurrence (Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Restricted to subjects who stop therapy due to disease clearance. Time to disease recurrence is defined as the time from the last dose of ARQ-151 to the 
first observation of an IGA score of 2 or greater.  The time to disease recurrence among subjects with clearance at the end of the study observation period 
will be censored at the last observed disease assessment.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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CONFIDENTIAL
Table 14.2.10.2: Summary of Time to Disease Recurrence
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Duration of PASI-75 (Weeks)
n
xx
Mediana
xx
  Disease Recurrence
xx (
xx%)
  Censored
xx (
xx%)
a Median determined using the Kaplan-Meier method. 
Note: Restricted to subjects who stop therapy due to disease clearance. Time to disease recurrence is defined as the time from the last dose of ARQ-151 to the 
first observation of an IGA score of 2 or greater.  The time to disease recurrence among subjects with clearance at the end of the study observation period 
will be censored at the last observed disease assessment. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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CONFIDENTIAL
Table 14.2.10.3: Summary of Time to Disease Recurrence
(Safety Population)
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Duration of PASI-75 (Weeks)
n
xx
xx
xx
Mediana
xx
xx
xx
  Disease Recurrence
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Restricted to subjects who stop therapy due to disease clearance. Time to disease recurrence is defined as the time from the last dose of ARQ-151 to the 
first observation of an IGA score of 2 or greater.  The time to disease recurrence among subjects with clearance at the end of the study observation period 
will be censored at the last observed disease assessment. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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CONFIDENTIAL
Table 14.2.11.1: Summary of Disease Control
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201: 
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Time to Disease Control (Weeks)
n
xx
xx
xx
xx
Mediana
xx
xx
xx
xx
  Disease Control
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Restricted to subjects who restart therapy after having stopped therapy due to disease clearance.  Time to disease control is the time from the restart of 
therapy to the first reported IGA score of Clear or Almost Clear. The time to disease control among subjects who do not achieve an IGA score of Clear or 
Almost Clear by the end of the study observation period will be censored at the last observed disease assessment. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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CONFIDENTIAL
Table 14.2.11.2: Summary of Disease Control
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Time to Disease Control (Weeks)
n
xx
Mediana
xx
  Disease Control
xx (
xx%)
  Censored
xx (
xx%)
a Median determined using the Kaplan-Meier method. 
Note: Restricted to subjects who restart therapy after having stopped therapy due to disease clearance.  Time to disease control is the time from the restart of 
therapy to the first reported IGA score of 0 or 1. The time to disease control among subjects who do not achieve an IGA score of 0 or 1 by the end of the 
study observation period will be censored at the last observed disease assessment.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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CONFIDENTIAL
Table 14.2.11.3: Summary of Disease Control
(Safety Population)
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Time to Disease Control (Weeks)
n
xx
xx
xx
Mediana
xx
xx
xx
  Disease Control
xx (
xx%)
xx (
xx%)
xx (
xx%)
  Censored
xx (
xx%)
xx (
xx%)
xx (
xx%)
a Median determined using the Kaplan-Meier method.   
Note: Restricted to subjects who restart therapy after having stopped therapy due to disease clearance.  Time to disease control is the time from the restart of 
therapy to the first reported IGA score of 0 or 1. The time to disease control among subjects who do not achieve an IGA score of 0 or 1 by the end of the 
study observation period will be censored at the last observed disease assessment.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)




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CONFIDENTIAL
Table 14.3.0.1.1: Summary of Extent of Exposure
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Number of Applications
N
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Amount of Drug Used (g)
N
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Completed >= 80% of Expected Doses
xx ( xx%)
xx ( xx%)
xx ( xx%)
xx ( xx%)
Completed < 80% of Expected Doses
xx ( xx%)
xx ( xx%)
xx ( xx%)
xx ( xx%)
Complianta
xx ( xx%)
xx ( xx%)
xx ( xx%)
xx ( xx%)
Not Compliant
xx ( xx%)
xx ( xx%)
xx ( xx%)
xx ( xx%)
a A subject was considered compliant with the dosing regimen if the subject did not miss more than 3 consecutive days dosing and applied >= 80% of expected 
doses while participating in the study. 
Note: Lost to Follow-Up subjects were included using all available information.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.0.1.2: Summary of Extent of Exposure
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Number of Applications
N
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Amount of Drug Used (g)
N
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Completed >= 80% of Expected Doses
xx ( xx%)
Completed < 80% of Expected Doses
xx ( xx%)
Complianta
xx ( xx%)
Not Compliant
xx ( xx%)
a A subject was considered compliant with the dosing regimen if the subject did not miss more than 3 consecutive days dosing and applied >= 80% of expected 
doses while participating in the study. 
Note: Lost to Follow-Up subjects were included using all available information.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.0.1.3: Summary of Extent of Exposure
(Safety Population)
 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Number of Applications
N
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Amount of Drug Used (g)
N
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Completed >= 80% of Expected Doses
xx ( xx%)
xx ( xx%)
xx ( xx%)
Completed < 80% of Expected Doses
xx ( xx%)
xx ( xx%)
xx ( xx%)
Complianta
xx ( xx%)
xx ( xx%)
xx ( xx%)
Not Compliant
xx ( xx%)
xx ( xx%)
xx ( xx%)
a A subject was considered compliant with the dosing regimen if the subject did not miss more than 3 consecutive days dosing and applied >= 80% of expected 
doses while participating in the study. 
Note: Lost to Follow-Up subjects were included using all available information. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.1.1: Summary of Local Tolerability
(Safety Population: Cohort 1)
(Page 1 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Local Tolerability Dermal Response
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 4
n
xx
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.1.1: Summary of Local Tolerability
(Safety Population: Cohort 1)
(Page 2 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Local Tolerability Dermal Response
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 24
n
xx
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.1.1: Summary of Local Tolerability
(Safety Population: Cohort 1)
(Page 3 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Local Tolerability Dermal Response
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 52
n
xx
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.1.2: Summary of Local Tolerability
(Safety Population: Cohort 2)
(Page 1 of 3)
Investigator Local Tolerability Dermal Response
Roflumilast Cream 0.3%
(N=xx)
Baseline
n
xx
0 - no evidence of irritation
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
Week 4
n
xx
0 - no evidence of irritation
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.1.2: Summary of Local Tolerability
(Safety Population: Cohort 2) 
(Page 2 of 3)
Investigator Local Tolerability Dermal Response
Roflumilast Cream 0.3%
(N=xx)
Week 12
n
xx
0 - no evidence of irritation
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
Week 24
n
xx
0 - no evidence of irritation
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.1.2: Summary of Local Tolerability
(Safety Population: Cohort 2) 
(Page 3 of 3)
Investigator Local Tolerability Dermal Response
Roflumilast Cream 0.3%
(N=xx)
Week 36
n
xx
0 - no evidence of irritation
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
Week 52
n
xx
0 - no evidence of irritation
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.1.3: Summary of Local Tolerability
(Safety Population) 
(Page 1 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Local Tolerability Dermal Response
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 4
n
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.1.3: Summary of Local Tolerability
(Safety Population) 
(Page 2 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Local Tolerability Dermal Response
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2 
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 24
n
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.1.3: Summary of Local Tolerability
(Safety Population) 
(Page 3 of 3)
ARQ-151-202: Roflumilast Cream 0.3%
Investigator Local Tolerability Dermal Response
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
     edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 52
n
xx
xx
xx
0 - no evidence of irritation
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1 - minimal erythema, barely perceptible
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2 - definite erythema, readily visible; minimal 
edema or minimal popular response
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3 - erythema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4 - definite edema
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5 - erythema, edema and papules
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6 - vesicular eruption
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7 - strong reaction spreading beyond application
site
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.2.1: Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8)
(Safety Population: Cohort 1)
(Page 1 of 2)
ARQ-151-202: Roflumilast Cream 0.3%
Patient Health Questionnaire Depression Scale
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 4
n
xx
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 12
n
xx
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.2.1: Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8)
(Safety Population: Cohort 1)
(Page 2 of 2)
ARQ-151-202: Roflumilast Cream 0.3%
Patient Health Questionnaire Depression Scale
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 36
n
xx
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 52
n
xx
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.2.2: Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8)
(Safety Population: Cohort 2)
(Page 1 of 2)
Patient Health Questionnaire Depression Scale
Roflumilast Cream 0.3%
(N=xx)
Baseline
n
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
Week 4
n
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
Week 12
n
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 208 of 337
CONFIDENTIAL
Table 14.3.1.2.2: Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8)
(Safety Population: Cohort 2) 
(Page 2 of 2)
Patient Health Questionnaire Depression Scale
Roflumilast Cream 0.3%
(N=xx)
Week 24
n
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
Week 36
n
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
Week 52
n
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.2.3: Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8)
(Safety Population) 
(Page 1 of 2)
ARQ-151-202: Roflumilast Cream 0.3%
Patient Health Questionnaire Depression Scale
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 4
n
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 12
n
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 210 of 337
CONFIDENTIAL
Table 14.3.1.2.3: Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8)
(Safety Population) 
(Page 2 of 2)
ARQ-151-202: Roflumilast Cream 0.3%
Patient Health Questionnaire Depression Scale
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 24
n
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 36
n
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 52
n
xx
xx
xx
None - Minimal Depression ( 0 to 4)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Mild Depression (5 to 9)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderate Depression (10 to 14)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Moderately Severe Depression  (15 to 19)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Severe Depression (20 to 24)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.3.1: Shift Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8) by Treatment Group
(Safety Population: Cohort 1)
(Page 1 of 8) 
PHQ-8 for (ARQ-151-201: Roflumilast Cream 0.3%)
Week 4
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 12
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 24
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression ( 5 to 9); Moderate = Moderate Depression (10 to 14);
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24).
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 212 of 337
CONFIDENTIAL
Table 14.3.1.3.1: Shift Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8) by Treatment Group
(Safety Population: Cohort 1)
(Page 2 of 8) 
PHQ-8 for (ARQ-151-201: Roflumilast Cream 0.3%)
Week 36
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 52
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression ( 5 to 9); Moderate = Moderate Depression (10 to 14);
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24).
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to Programmer - Repeat for each treatment group (ARQ-151-201: Roflumilast Cream 0.15%; ARQ-151-201: 
Vehicle Cream; Total)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 213 of 337
CONFIDENTIAL
Table 14.3.1.3.2: Shift Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8) by Treatment Group
(Safety Population: Cohort 2)
(Page 1 of 2) 
PHQ-8 for (Roflumilast Cream 0.3%)
Week 4
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 12
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 24
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression ( 5 to 9); Moderate = Moderate Depression (10 to 14);
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.3.2: Shift Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8) by Treatment Group
(Safety Population: Cohort 2) 
(Page 2 of 2) 
PHQ-8 for (Roflumilast Cream 0.3%)
Week 36
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 52
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression ( 5 to 9); Moderate = Moderate Depression (10 to 14);
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to Programmer - Do not repeat for any other treatements.


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CONFIDENTIAL
Table 14.3.1.3.3: Shift Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8) by Treatment Group
(Safety Population) 
(Page 1 of 6) 
PHQ-8 for (ARQ-151-201: Roflumilast Cream)
Week 4
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 12
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 24
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression ( 5 to 9); Moderate = Moderate Depression (10 to 14);
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24).
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.3.3: Shift Summary of Patient Health Questionnaire Depression Scale Assessments (PHQ-8) by Treatment Group
(Safety Population) 
(Page 2 of 6) 
PHQ-8 for (ARQ-151-201: Roflumilast Cream)
Week 36
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Week 52
Baseline
None
Mild
Moderate
Moderately Severe
Severe
None
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Mild
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderate
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Moderately Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Severe
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
xx
( xx.x%)
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression ( 5 to 9); Moderate = Moderate Depression (10 to 14);
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24).
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to Programmer - Repeat for each treatment group (ARQ-151-201: Vehicle Cream and Cohort 2; Total) 


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CONFIDENTIAL
Table 14.3.1.4.1.1: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-Inurious Behavior without Suicidal Intent Based on the Columbia-
Suicide Severity Rating Scale (C-SSRS) During Treatment
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
Events During Treatment
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Suicidal Ideation (1-5)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1) Wish to be dead
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2) Non-specific active suicidal thoughts
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3) Active suicidal ideation with any methods 
(not plan) without intent to act
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4) Active suicidal ideation with some intent to 
act, without specific plan
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5) Active suicidal ideation with specific plan
and intent
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Suicidal Behavior (6-10)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6) Preparatory acts or behavior
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7) Aborted attempt
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
8) Interrupted attempt
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
9) Non-fatal suicide attempt
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
10) Completed Suicide
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Suicidal Ideation or Behavior (1-10)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Self-injurious behavior without suicidal intent
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.4.1.2: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-Inurious Behavior without Suicidal Intent Based on the Columbia-
Suicide Severity Rating Scale (C-SSRS) During Treatment
(Safety Population: Cohort 1)
Events During Treatment
Roflumilast Cream 0.3%
(N=xx)
Suicidal Ideation (1-5)
xx ( xx.x%)
1) Wish to be dead
xx ( xx.x%)
2) Non-specific active suicidal thoughts
xx ( xx.x%)
3) Active suicidal ideation with any methods 
    (not plan) without intent to act
xx ( xx.x%)
4) Active suicidal ideation with some intent to 
act, without specific plan
xx ( xx.x%)
5) Active suicidal ideation with specific plan
and intent
xx ( xx.x%)
Suicidal Behavior (6-10)
xx ( xx.x%)
6) Preparatory acts or behavior
xx ( xx.x%)
7) Aborted attempt
xx ( xx.x%)
8) Interrupted attempt
xx ( xx.x%)
9) Non-fatal suicide attempt
xx ( xx.x%)
10) Completed Suicide
xx ( xx.x%)
Suicidal Ideation or Behavior (1-10)
xx ( xx.x%)
Self-injurious behavior without suicidal intent
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.4.1.3: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-Inurious Behavior without Suicidal Intent Based on the Columbia-
Suicide Severity Rating Scale (C-SSRS) During Treatment
(Safety Population) 
ARQ-151-202: Roflumilast Cream 0.3%
Events During Treatment
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Suicidal Ideation (1-5)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
1) Wish to be dead
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
2) Non-specific active suicidal thoughts
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
3) Active suicidal ideation with any methods 
    (not plan) without intent to act
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
4) Active suicidal ideation with some intent to 
act, without specific plan
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
5) Active suicidal ideation with specific plan
and intent
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Suicidal Behavior (6-10)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
6) Preparatory acts or behavior
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
7) Aborted attempt
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
8) Interrupted attempt
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
9) Non-fatal suicide attempt
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
10) Completed Suicide
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Suicidal Ideation or Behavior (1-10)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Self-injurious behavior without suicidal intent
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.1.4.2.1: Number of Patients with Suicidal-Related Treatment-Emergent Events Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) 
During Treatment
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
Treatment-Emergent (TE) Events
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
N
na (%)
N
na (%)
N
na (%)
N
na (%)
TE suicidal ideation (1-5) compared to 
recent history b 
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
TE serious suicidal ideation (0-3 to 4-5) 
compared to recent history c
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Emergence of serious suicidal ideation
(0 to 4-5) compared to recent history d
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Improvement in suicidal ideation at endpoint 
compared with baselined e
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Emergence of suicidal behavior (6-10) 
compared to all prior history f
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Note: Restricted to subjects with at least one post-treatment C-SSRS assessment. 
a Counts reflect numbers of subjects who experienced the event at least once post-treatment.
b N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
non-missing and <5.
c N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
0-3.
d N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
0.
e N=Number of subjects whose suicidal ideation score is non-missing and >0 just prior to treatment.
f N=Number of subjects with at least one post-baseline C-SSRS assessment and who did not have suicidal behavior (6-10) prior to treatment.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.4.2.2: Number of Patients with Suicidal-Related Treatment-Emergent Events Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) 
During Treatment
(Safety Population: Cohort 2)
Treatment-Emergent (TE) Events
Roflumilast Cream 0.3%
(N=xx)
N
na (%)
TE suicidal ideation (1-5) compared to 
recent history b 
xx
xx ( xx.x%)
TE serious suicidal ideation (0-3 to 4-5) 
compared to recent history c
xx
xx ( xx.x%)
Emergence of serious suicidal ideation
(0 to 4-5) compared to recent history d
xx
xx ( xx.x%)
Improvement in suicidal ideation at endpoint 
compared with baselined e
xx
xx ( xx.x%)
Emergence of suicidal behavior (6-10) 
compared to all prior history f
xx
xx ( xx.x%)
Note: Restricted to subjects with at least one post-treatment C-SSRS assessment. 
a Counts reflect numbers of subjects who experienced the event at least once post-treatment.
b N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
non-missing and <5.
c N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
0-3.
d N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
0.
e N=Number of subjects whose suicidal ideation score is non-missing and >0 just prior to treatment.
f N=Number of subjects with at least one post-baseline C-SSRS assessment and who did not have suicidal behavior (6-10) prior to treatment.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.1.4.2.3: Number of Patients with Suicidal-Related Treatment-Emergent Events Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) 
During Treatment
(Safety Population) 
ARQ-151-202: Roflumilast Cream 0.3%
Treatment-Emergent (TE) Events
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
N
na (%)
N
na (%)
N
na (%)
TE suicidal ideation (1-5) compared to 
recent history b 
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
TE serious suicidal ideation (0-3 to 4-5) 
compared to recent history c
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Emergence of serious suicidal ideation
(0 to 4-5) compared to recent history d
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Improvement in suicidal ideation at endpoint 
compared with baselined e
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Emergence of suicidal behavior (6-10) 
compared to all prior history f
xx
xx ( xx.x%)
xx
xx ( xx.x%)
xx
xx ( xx.x%)
Note: Restricted to subjects with at least one post-treatment C-SSRS assessment. 
a Counts reflect numbers of subjects who experienced the event at least once post-treatment.
b N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
non-missing and <5.
c N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
0-3.
d N=Number of subjects with at least one post-baseline suicidal ideation score and whose maximum C-SSRS suicidal ideation score during the past 6 months is
0.
e N=Number of subjects whose suicidal ideation score is non-missing and >0 just prior to treatment.
f N=Number of subjects with at least one post-baseline C-SSRS assessment and who did not have suicidal behavior (6-10) prior to treatment.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.2.1.1.1: Summary of Treatment-Emergent Adverse Event Characteristics
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Number (%) of Subjects Reporting At Least 
One TEAE
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of TEAEs
xx
xx
xx
xx
Number (%) of Subjects Reporting At Least 
One Serious Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of Serious TEAEs
xx
xx
xx
xx
Number (%) of Subjects who Died
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number (%) of Subjects who Discontinued 
Study Drug due to Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Severity by Subject
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Relationship by Subject 
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Repeat Table 14.3.2.1.1.1.:  Summary of Treatment Emergent Adverse Events Characteristics and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.1.1.2: Summary of Post Active Treatment-Emergent Adverse Events Characteristics (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 225 of 337
CONFIDENTIAL
Table 14.3.2.1.2: Summary of Treatment-Emergent Adverse Event Characteristics
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Number (%) of Subjects Reporting At Least 
One TEAE
xx ( xx.x%)
Number of TEAEs
xx
Number (%) of Subjects Reporting At Least 
One Serious Adverse Event
xx ( xx.x%)
Number of Serious TEAEs
xx
Number (%) of Subjects who Died
xx ( xx.x%)
Number (%) of Subjects who Discontinued 
Study Drug due to Adverse Event
xx ( xx.x%)
Maximum Severity by Subject
Grade 5
xx ( xx.x%)
Grade 4
xx ( xx.x%)
Grade 3
xx ( xx.x%)
Grade 2
xx ( xx.x%)
Grade 1
xx ( xx.x%)
Maximum Relationship by Subject 
Likely
xx ( xx.x%)
Probably
xx ( xx.x%)
Possibly
xx ( xx.x%)
Unlikely
xx ( xx.x%)
Unrelated
xx ( xx.x%)
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.2.1.3.1: Summary of Treatment-Emergent Adverse Event Characteristics 
(Safety Population) 
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Number (%) of Subjects Reporting At Least 
One TEAE
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of TEAEs
xx
xx
xx
Number (%) of Subjects Reporting At Least 
One Serious Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of Serious TEAEs
xx
xx
xx
Number (%) of Subjects who Died
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number (%) of Subjects who Discontinued 
Study Drug due to Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Severity by Subject
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Relationship by Subject 
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 227 of 337
CONFIDENTIAL
Repeat Table 14.3.2.1.3.1.:  Summary of Treatment Emergent Adverse Events Characteristics and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.1.3.2: Summary of Post Active Treatment-Emergent Adverse Events Characteristics (Safety Population)  


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 228 of 337
CONFIDENTIAL
Table 14.3.2.2.1.1: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
System Organ Class
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once.
Note: MedDRA dictionary (Version xx)
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to the programmer: Sort the table by descending total frequency of system organ class and descending total frequency 
of preferred terms within each system organ class. Sort all remaining AE tables in the same fashion.


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 229 of 337
CONFIDENTIAL
Table 14.3.2.2.1.2: Summary of Post Active Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
System Organ Class
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once.  
Note: MedDRA dictionary (Version xx)  
Note: Post active treatment-emergent adverse event defined as event with an onset on or after the date of the first dose of active study drug application in either 
ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.2.2.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term
(Safety Population: Cohort 2)
(Page 1 of xx)
System Organ Classa
Preferred Term
Roflumilast Cream 0.3%
(N=xx)
System Organ Class
xx ( xx.x%)
Preferred Term
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once.  
Note: MedDRA dictionary (Version xx)  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.2.2.3.1: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
System Organ Class
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once.
Note: MedDRA dictionary (Version xx)  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to the programmer: Sort the table by alphabetical order of system organ class and descending total frequency of 
preferred terms within each system organ class. Sort all remaining AE tables in the same fashion.


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 232 of 337
CONFIDENTIAL
Repeat Table 14.3.2.2.3.1.:  Summary of Treatment Emergent Adverse Events by MedDRA System Organ Class and Preferred Term -  
and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.2.3.2: Summary of Post Active Treatment-Emergent Adverse Events System Organ Class and Preferred Term (Safety Population) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 233 of 337
CONFIDENTIAL
Table 14.3.2.3.1.1: Summary of Treatment-Emergent Adverse Events by Severity
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Severity
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
System Organ Class
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once under the greatest reported severity.
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
    
MedDRA dictionary (Version xx)  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 234 of 337
CONFIDENTIAL
Repeat Table 14.3.2.3.1.1.:  Summary of Treatment Emergent Adverse Events by Severity - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.3.1.2: Summary of Post Active Treatment-Emergent Adverse Events by Severity (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 235 of 337
CONFIDENTIAL
Table 14.3.2.3.2: Summary of Treatment-Emergent Adverse Events by Severity
(Safety Population: Cohort 2)
(Page 1 of xx)
System Organ Classa
Preferred Term
Severity
Roflumilast Cream 0.3%
(N=xx)
System Organ Class
Grade 5
xx ( xx.x%)
Grade 4
xx ( xx.x%)
Grade 3
xx ( xx.x%)
Grade 2
xx ( xx.x%)
Grade 1
xx ( xx.x%)
Preferred Term
Grade 5
xx ( xx.x%)
Grade 4
xx ( xx.x%)
Grade 3
xx ( xx.x%)
Grade 2
xx ( xx.x%)
Grade 1
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once under the greatest reported severity.  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application.
    
MedDRA dictionary (Version xx)  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.2.3.3.1: Summary of Treatment-Emergent Adverse Events by Severity
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Severity
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
System Organ Class
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once under the greatest reported severity.
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
MedDRA dictionary (Version xx)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 237 of 337
CONFIDENTIAL
Repeat Table 14.3.2.3.3.1.:  Summary of Treatment Emergent Adverse Events by Severity - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.3.3.2: Summary of Post Active Treatment-Emergent Adverse Events by Severity (Safety Population) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 238 of 337
CONFIDENTIAL
Table 14.3.2.4.1.1: Summary of Treatment-Emergent Adverse Events by Relationship
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Relationship
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
System Organ Class
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once under the strongest reported relationship.  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
MedDRA dictionary (Version xx)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 239 of 337
CONFIDENTIAL
Repeat Table 14.3.2.4.1.1.:  Summary of Treatment Emergent Adverse Events by Relationship - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.4.1.2: Summary of Post Active Treatment-Emergent Adverse Events by Relationship (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 240 of 337
CONFIDENTIAL
Table 14.3.2.4.2: Summary of Treatment-Emergent Adverse Events by Relationship
(Safety Population: Cohort 2)
(Page 1 of xx)
System Organ Classa
Preferred Term
Relationship
Roflumilast Cream 0.3%
(N=xx)
System Organ Class
Likely
xx ( xx.x%)
Probably
xx ( xx.x%)
Possibly
xx ( xx.x%)
Unlikely
xx ( xx.x%)
Unrelated
xx ( xx.x%)
Preferred Term
Likely
xx ( xx.x%)
Probably
xx ( xx.x%)
Possibly
xx ( xx.x%)
Unlikely
xx ( xx.x%)
Unrelated
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once under the strongest reported relationship.
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application.
          MedDRA dictionary (Version xx)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 241 of 337
CONFIDENTIAL
Table 14.3.2.4.3.1: Summary of Treatment-Emergent Adverse Events by Relationship
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Relationship
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
System Organ Class
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once under the strongest reported relationship.  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
MedDRA dictionary (Version xx)SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 242 of 337
CONFIDENTIAL
Repeat Table 14.3.2.4.3.1: Summary of Treatment Emergent Adverse Events by Relationship - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.4.3.2: Summary of Post Active Treatment-Emergent Adverse Events by Relationship (Safety Population) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 243 of 337
CONFIDENTIAL
Table 14.3.2.5.1.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics
(Safety Population: Cohort 1)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Number (%) of Subjects Reporting At Least 
One Serious Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of Serious TEAEs
xx
xx
xx
xx
Number (%) of Subjects who Died
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number (%) of Subjects who Discontinued 
Study Drug due to Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Severity by Subject
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Relationship by Subject 
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 244 of 337
CONFIDENTIAL
Repeat Table 14.3.2.5.1.1.:  Summary of Treatment Emergent Serious Adverse Events Characteristics - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.5.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events Characteristics (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 245 of 337
CONFIDENTIAL
Table 14.3.2.5.2: Summary of Treatment-Emergent Serious Adverse Event Characteristics
(Safety Population: Cohort 2)
Roflumilast Cream 0.3%
(N=xx)
Number (%) of Subjects Reporting At Least 
One Serious Adverse Event
xx ( xx.x%)
Number of Serious TEAEs
xx
Number (%) of Subjects who Died
xx ( xx.x%)
Number (%) of Subjects who Discontinued 
Study Drug due to Adverse Event
xx ( xx.x%)
Maximum Severity by Subject
Grade 5
xx ( xx.x%)
Grade 4
xx ( xx.x%)
Grade 3
xx ( xx.x%)
Grade 2
xx ( xx.x%)
Grade 1
xx ( xx.x%)
Maximum Relationship by Subject 
Likely
xx ( xx.x%)
Probably
xx ( xx.x%)
Possibly
xx ( xx.x%)
Unlikely
xx ( xx.x%)
Unrelated
xx ( xx.x%)
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.2.5.3.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics
(Safety Population)
ARQ-151-202: Roflumilast Cream 0.3%
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Number (%) of Subjects Reporting At Least 
One Serious Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number of Serious TEAEs
xx
xx
xx
Number (%) of Subjects who Died
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Number (%) of Subjects who Discontinued 
Study Drug due to Adverse Event
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Severity by Subject
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maximum Relationship by Subject 
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 247 of 337
CONFIDENTIAL
Repeat Table 14.3.2.5.3.1.:  Summary of Treatment Emergent Serious Adverse Events Characteristics - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.5.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events Characteristics (Safety Population) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 248 of 337
CONFIDENTIAL
Table 14.3.2.6.1.1: Summary of Treatment-Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
System Organ Class
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once.
Note: MedDRA dictionary (Version xx)  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 249 of 337
CONFIDENTIAL
Repeat Table 14.3.2.6.1.1.:  Summary of Treatment Emergent Serious Adverse Events by MedDRA System Organ Class and 
Preferred Term- and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.6.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term (Safety 
Population: Cohort 1)


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CONFIDENTIAL
Table 14.3.2.6.2: Summary of Treatment-Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term
(Safety Population: Cohort 2)
(Page 1 of xx)
System Organ Classa
Preferred Term
Roflumilast Cream 0.3%
(N=xx)
System Organ Class
xx ( xx.x%)
Preferred Term
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once.  
Note: MedDRA dictionary (Version xx)  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 251 of 337
CONFIDENTIAL
Table 14.3.2.6.3.1: Summary of Treatment-Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
ARQ-151-201:
Roflumilast Cream 
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
System Organ Class
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or
Preferred Term) subjects are counted once.
Note: MedDRA dictionary (Version xx)
Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 252 of 337
CONFIDENTIAL
Repeat Table 14.3.2.6.3.1: Summary of Treatment Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred 
Term- and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.6.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term (Safety 
Population)


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Page 253 of 337
CONFIDENTIAL
Table 14.3.2.7.1.1: Summary of Treatment-Emergent Serious Adverse Events by Severity
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Severity
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
System Organ Class
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more serious adverse events that map to MedDRA. At each level of summarization
(System Organ Class or Preferred Term) subjects are counted once under the greatest reported severity.
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
MedDRA dictionary (Version xx)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 254 of 337
CONFIDENTIAL
Repeat Table 14.3.2.7.1.1.:  Summary of Treatment Emergent Serious Adverse Events by Severity- and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.7.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by Severity (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 255 of 337
CONFIDENTIAL
Table 14.3.2.7.2: Summary of Treatment-Emergent Serious Adverse Events by Severity
(Safety Population: Cohort 2)
(Page 1 of xx)
System Organ Classa
Preferred Term
Severity
Roflumilast Cream 0.3%
(N=xx)
System Organ Class
Grade 5
xx ( xx.x%)
Grade 4
xx ( xx.x%)
Grade 3
xx ( xx.x%)
Grade 2
xx ( xx.x%)
Grade 1
xx ( xx.x%)
Preferred Term
Grade 5
xx ( xx.x%)
Grade 4
xx ( xx.x%)
Grade 3
xx ( xx.x%)
Grade 2
xx ( xx.x%)
Grade 1
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more serious adverse events that map to MedDRA. At each level of summarization
(System Organ Class or Preferred Term) subjects are counted once under the greatest reported severity.  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application.
MedDRA dictionary (Version xx)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.2.7.3.1: Summary of Treatment-Emergent Serious Adverse Events by Severity
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Severity
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
System Organ Class
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Grade 5
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 4
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 3
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 2
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Grade 1
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more serious adverse events that map to MedDRA. At each level of summarization
(System Organ Class or Preferred Term) subjects are counted once under the greatest reported severity.  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
MedDRA dictionary (Version xx)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 257 of 337
CONFIDENTIAL
Repeat Table 14.3.2.7.3.1: Summary of Treatment Emergent Serious Adverse Events by Severity- and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.7.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by Severity (Safety Population) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 258 of 337
CONFIDENTIAL
Table 14.3.2.8.1.1: Summary of Treatment-Emergent Serious Adverse Events by Relationship
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Relationship
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
System Organ Class
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more serious adverse events that map to MedDRA. At each level of summarization 
(System Organ Class or Preferred Term) subjects are counted once under the strongest reported relationship.
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
MedDRA dictionary (Version xx)  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 259 of 337
CONFIDENTIAL
Repeat Table 14.3.2.8.1.1.:  Summary of Treatment Emergent Serious Adverse Events by Relationship - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.8.1.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by Relationship (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 260 of 337
CONFIDENTIAL
Table 14.3.2.8.2: Summary of Treatment-Emergent Serious Adverse Events by Relationship
(Safety Population: Cohort 2)
(Page 1 of xx)
System Organ Classa
Preferred Term
Relationship
Roflumilast Cream 0.3%
(N=xx)
System Organ Class
Likely
xx ( xx.x%)
Probably
xx ( xx.x%)
Possibly
xx ( xx.x%)
Unlikely
xx ( xx.x%)
Unrelated
xx ( xx.x%)
Preferred Term
Likely
xx ( xx.x%)
Probably
xx ( xx.x%)
Possibly
xx ( xx.x%)
Unlikely
xx ( xx.x%)
Unrelated
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more serious adverse events that map to MedDRA. At each level of summarization 
(System Organ Class or Preferred Term) subjects are counted once under the strongest reported relationship.  
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application.
MedDRA dictionary (Version xx)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.2.8.3.1: Summary of Treatment-Emergent Serious Adverse Events by Relationship
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
System Organ Classa
Preferred Term
Relationship
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
System Organ Class
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Preferred Term
Likely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Probably
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Possibly
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unlikely
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Unrelated
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
a Counts reflect numbers of subjects reporting one or more serious adverse events that map to MedDRA. At each level of summarization 
(System Organ Class or Preferred Term) subjects are counted once under the strongest reported relationship.
Note: Treatment-emergent adverse event defined as event with an onset on or after the date of the first study drug application in ARQ-151-202 study.
MedDRA dictionary (Version xx)  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 262 of 337
CONFIDENTIAL
Repeat Table 14.3.2.8.3.1.:  Summary of Treatment Emergent Serious Adverse Events by Relationship - and update footnote to:
Note: Post active treatment-emergent adverse event defined as event with an onset date on or after the date of first dose of active study drug in 
either ARQ-151-201 or ARQ-151-202.:
For the following tables:
Table 14.3.2.8.3.2: Summary of Post Active Treatment-Emergent Serious Adverse Events by Relationship (Safety Subjects)  


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 263 of 337
CONFIDENTIAL
Table 14.3.3.1.1.1: Summary of Chemistry Laboratory Results
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 4
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.3.1.1.1: Summary of Chemistry Laboratory Results
(Safety Population: Cohort 1)
(Page 2 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 24
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.3.1.1.1: Summary of Chemistry Laboratory Results
(Safety Population: Cohort 1)
(Page 3 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 52
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 266 of 337
CONFIDENTIAL
Repeat Table 14.3.3.1.1.1: Summary of Chemistry Laboratory Results 
For the following tables:
Table 14.3.3.1.2.1: Summary of Hematology Laboratory Results (Safety Population: Cohort 1)
Table 14.3.3.1.3.1: Summary of Urinalysis Laboratory Results (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 267 of 337
CONFIDENTIAL
Table 14.3.3.1.1.2: Summary of Chemistry Laboratory Results
(Safety Population: Cohort 2)
(Page 1 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Week 4
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 268 of 337
CONFIDENTIAL
Table 14.3.3.1.1.2: Summary of Chemistry Laboratory Results
(Safety Population: Cohort 2) 
(Page 2 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Week 12
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Week 24
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 269 of 337
CONFIDENTIAL
Table 14.3.3.1.1.2: Summary of Chemistry Laboratory Results
(Safety Population: Cohort 2) 
(Page 3 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Week 36
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Week 52
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 270 of 337
CONFIDENTIAL
Repeat Table 14.3.3.1.1.2: Summary of Chemistry Laboratory Results
For the following tables:
Table 14.3.3.1.2.2: Summary of Hematology Laboratory Results (Safety Population: Cohort 2)
Table 14.3.3.1.3.2: Summary of Urinalysis Laboratory Results (Safety Population: Cohort 2)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 271 of 337
CONFIDENTIAL
Table 14.3.3.1.1.3: Summary of Chemistry Laboratory Results
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Week 4
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 272 of 337
CONFIDENTIAL
Table 14.3.3.1.1.3: Summary of Chemistry Laboratory Results
(Safety Population)
(Page 2 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Week 24
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 273 of 337
CONFIDENTIAL
Table 14.3.3.1.1.3: Summary of Chemistry Laboratory Results
(Safety Population)
(Page 3 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Week 52
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 274 of 337
CONFIDENTIAL
Repeat Table 14.3.3.1.1.3: Summary of Chemistry Laboratory Results 
For the following tables:
Table 14.3.3.1.2.3: Summary of Hematology Laboratory Results (Safety Population)
Table 14.3.3.1.3.3: Summary of Urinalysis Laboratory Results (Safety Population)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 275 of 337
CONFIDENTIAL
Table 14.3.3.2.1.1: Shift Summary of Chemistry Lab Results
(Safety Population: Cohort 1)
(Page 1 of x)
<Test Name> (<units>)
Week 4
Roflumilast Cream 0.3% (N=xx)
Roflumilast Cream 0.15% (N=xx)
Baseline
BNL
WNL
ANL
BNL
WNL
ANL
BNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
WNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
ANL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Vehicle Cream  (N=xx)
Total (N=xx)
Baseline
BNL
WNL
ANL
BNL
WNL
ANL
BNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
WNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
ANL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit.
 
 Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to Programmer: Repeat for Visits: Week 12, Week 24, Week 36, Week 52
Repeat table 14.3.3.2.1.1 Shift Summary of Chemistry Lab Results 
For the following tables:
Table 14.3.3.2.2.1: Shift Summary of Hematology Laboratory Results (Safety Population: Cohort 1)
Table 14.3.3.2.3.1: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety Population: Cohort 1)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 276 of 337
CONFIDENTIAL
Table 14.3.3.2.1.2: Shift Summary of Chemistry Lab Results
(Safety Population: Cohort 2)
(Page 1 of x)
<Test Name> (<units>)
Week 4
Roflumilast Cream 0.3% (N=xx)
Baseline
BNL
WNL
ANL
BNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
WNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
ANL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to Programmer: Repeat for Visits: Week 12, Week 24, Week 36, Week 52
Repeat table 14.3.3.2.1.2 Shift Summary of Chemistry Lab Results 
For the following tables:
Table 14.3.3.2.2.2: Shift Summary of Hematology Laboratory Results (Safety Population: Cohort 2)
Table 14.3.3.2.3.2: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety Population: Cohort 2)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 277 of 337
CONFIDENTIAL
Table 14.3.3.2.1.3: Shift Summary of Chemistry Lab Results
(Safety Population)
(Page 1 of x)
<Test Name> (<units>)
Week 4
ARQ-151-201: Roflumilast Cream (N=xx)
ARQ-151-201: Vehicle Cream
and Cohort 2 (N=xx)
Baseline
BNL
WNL
ANL
BNL
WNL
ANL
BNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
WNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
ANL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Total  (N=xx)
Baseline
BNL
WNL
ANL
BNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
WNL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
ANL
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit.  
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note to Programmer: Repeat for Visits: Week 12, Week 24, Week 36, Week 52
Repeat table 14.3.3.2.1.3 Shift Summary of Chemistry Lab Results 
For the following tables:
Table 14.3.3.2.2.3: Shift Summary of Hematology Laboratory Results (Safety Population)
Table 14.3.3.2.3.3: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety Population)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 278 of 337
CONFIDENTIAL
Table 14.3.4.1: Summary of Electrocardiogram (ECG) Parameters
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 24
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 279 of 337
CONFIDENTIAL
Table 14.3.4.1: Summary of Electrocardiogram (ECG) Parameters
(Safety Population: Cohort 1)
(Page 2 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 280 of 337
CONFIDENTIAL
Table 14.3.4.2: Summary of Electrocardiogram (ECG) Parameters
(Safety Population: Cohort 2) 
(Page 1 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Week 24
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 281 of 337
CONFIDENTIAL
Table 14.3.4.2: Summary of Electrocardiogram (ECG) Parameters
(Safety Population: Cohort 2) 
(Page 2 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Week 52
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 282 of 337
CONFIDENTIAL
Table 14.3.4.3: Summary of Electrocardiogram (ECG) Parameters
(Safety Population) 
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Week 24
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 283 of 337
CONFIDENTIAL
Table 14.3.4.3: Summary of Electrocardiogram (ECG) Parameters
(Safety Population)
(Page 2 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 52
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 284 of 337
CONFIDENTIAL
Table 14.3.5.1.1: Summary of Vital Signs
(Safety Population: Cohort 1)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 4
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 285 of 337
CONFIDENTIAL
Table 14.3.5.1.1: Summary of Vital Signs
(Safety Population: Cohort 1)
(Page 2 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 24
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.5.1.1: Summary of Vital Signs
(Safety Population: Cohort 1)
(Page 3 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Week 52
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
xx
Mean
xx.x
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.3.5.1.2: Summary of Vital Signs
(Safety Population: Cohort 2)
(Page 1 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Week 4
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.3.5.1.2: Summary of Vital Signs
(Safety Population: Cohort 2) 
(Page 2 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Week 12
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Week 24
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.5.1.2: Summary of Vital Signs
(Safety Population: Cohort 2) 
(Page 3 of xx)
<Parameter> (<units>)
Roflumilast Cream 0.3%
(N=xx)
Week 36
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Week 52
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
Change from Baseline
n
xx
Mean
xx.x
SD
xx.xx
Median
xx.x
Min. to Max.
xx to xx
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.5.1.3: Summary of Vital Signs
(Safety Population)
(Page 1 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Week 4
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.3.5.1.3: Summary of Vital Signs
(Safety Population)
(Page 2 of xx)
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 12
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Week 24
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.5.1.3: Summary of Vital Signs
(Safety Population)
(Page 3 of xx) 
ARQ-151-202: Roflumilast Cream 0.3%
<Parameter> (<units>)
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Week 52
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Change from Baseline
n
xx
xx
xx
Mean
xx.x
xx.x
xx.x
SD
xx.xx
xx.xx
xx.xx
Median
xx.x
xx.x
xx.x
Min. to Max.
xx to xx
xx to xx
xx to xx
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.5.2.1: Summary of Change in Body Weight Compared to Baseline
(Safety Population: Cohort 1)
(Page 1 of 2) 
ARQ-151-202: Roflumilast Cream 0.3%
Change in Body Weight Compared to Baseline
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 4
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 12
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 24
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.5.2.1: Summary of Change in Body Weight Compared to Baseline
(Safety Population: Cohort 1)
(Page 2 of 2)
ARQ-151-202: Roflumilast Cream 0.3%
Change in Body Weight Compared to Baseline
ARQ-151-201:
Roflumilast Cream 0.3%
(N=xx)
ARQ-151-201:
Roflumilast Cream 0.15%
(N=xx)
ARQ-151-201:
Vehicle Cream
(N=xx)
Total
(N=xx)
Week 36
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 52
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.5.2.2: Summary of Change in Body Weight Compared to Baseline
(Safety Population: Cohort 2)
(Page 1 of 2) 
Change in Body Weight Compared to Baseline
Roflumilast Cream 0.3%
(N=xx)
Week 4
Lost >5% Body Weight
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
Week 12
Lost >5% Body Weight
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
Week 24
Lost >5% Body Weight
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
Week 36
Lost >5% Body Weight
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.5.2.2: Summary of Change in Body Weight Compared to Baseline
(Safety Population: Cohort 2) 
(Page 2 of 2)
Change in Body Weight Compared to Baseline
Roflumilast Cream 0.3%
(N=xx)
Week 52
Lost >5% Body Weight
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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CONFIDENTIAL
Table 14.3.5.2.3: Summary of Change in Body Weight Compared to Baseline
(Safety Population) 
(Page 1 of 2) 
ARQ-151-202: Roflumilast Cream 0.3%
Change in Body Weight Compared to Baseline
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 4
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 12
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 24
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.5.2.3: Summary of Change in Body Weight Compared to Baseline
(Safety Population)
(Page 2 of 2)
ARQ-151-202: Roflumilast Cream 0.3%
Change in Body Weight Compared to Baseline
ARQ-151-201:
Roflumilast Cream
(N=xx)
ARQ-151-201:
Vehicle Cream
and Cohort 2
(N=xx)
Total
(N=xx)
Week 36
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Week 52
Lost >5% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Lost >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Maintained Body Weight 
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >5% Body Weight  
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Gained >10% Body Weight
xx ( xx.x%)
xx ( xx.x%)
xx ( xx.x%)
Note: Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
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CONFIDENTIAL
Table 14.3.5.3.1: Shift Summary of Body Mass Index (BMI) Results 
(Safety Population: Cohort 1) 
(Page 1 of 2) 
  
Body Mass Index
Last BMI Record
Roflumilast Cream 0.3% (N=xx)
Roflumilast Cream 0.15% (N=xx)
Baseline
Under
Normal
Over
Obese
Under
Normal
Over
Obese
Under
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Normal
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Over
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Obese
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Vehicle Cream  (N=xx)
Total (N=xx)
Baseline
Under
Normal
Over
Obese
Under
Normal
Over
Obese
Under
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Normal
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Over
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Obese
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit.  
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note To Programmer: Repeat this page, with Highest BMI Record and Lowest BMI Record


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 300 of 337
CONFIDENTIAL
Table 14.3.5.3.2: Shift Summary of Body Mass Index (BMI) Results 
(Safety Population: Cohort 2) 
  
Body Mass Index
Roflumilast Cream 0.3% (N=xx)
Lowest BMI Record
Highest BMI Record
Baseline
Under
Normal
Over
Obese
Under
Normal
Over
Obese
Under
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Normal
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Over
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Obese
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Last BMI Record
Baseline
Under
Normal
Over
Obese
Under
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Normal
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Over
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Obese
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)


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Table 14.3.5.3.3: Shift Summary of Body Mass Index (BMI) Results 
(Safety Population) 
(Page 1 of 2) 
  
Body Mass Index
Last BMI Record
ARQ-151-201: Roflumilast Cream (N=xx)
ARQ-151-201: Vehicle Cream (N=xx)
Baseline
Under
Normal
Over
Obese
Under
Normal
Over
Obese
Under
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Normal
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Over
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Obese
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Total  (N=xx)
Baseline
Under
Normal
Over
Obese
Under
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Normal
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Over
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Obese
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
xx( xx.x%)
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit.   
Baseline is defined as the last observation prior to the first dose of Roflumilast cream in either the ARQ-151-201 or ARQ-151-202 study.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME)
Note To Programmer: Repeat this page, with Highest BMI Record and Lowest BMI Record


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11. INDEX OF PLANNED LISTINGS
Listing 16.2.1.1: End of Study Information .................................................................................304
Listing 16.2.1.2: Discontinued Subjects ......................................................................................305
Listing 16.2.2.1: Inclusion/Exclusion Criteria Violations ...........................................................306
Listing 16.2.2.2: Protocol Deviations ..........................................................................................307
Listing 16.2.3: Analysis Populations ...........................................................................................308
Listing 16.2.4.1: Subject Demographic Information ...................................................................309
Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................310
Listing 16.2.4.2.2: Medical/Surgical History ...............................................................................311
Listing 16.2.4.3.1: Unique Medication Names Coded to WHO-DD ATC Level 2 Terms and 
Preferred Names ..................................................................................312
Listing 16.2.4.3.2: Prior and Concomitant Medications ..............................................................313
Listing 16.2.4.4.1: Unique Therapies and Procedures Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................314
Listing 16.2.4.4.2: Prior and Concomitant Therapies and Procedures ........................................315
Listing 16.2.4.5: Physical Examination .......................................................................................316
Listing 16.2.5.1: Study Visit Compliance ....................................................................................317
Listing 16.2.5.2: Drug Accountability .........................................................................................318
Listing 16.2.5.3: Study Drug Application ....................................................................................319
Listing 16.2.5.4: Dosing Compliance ..........................................................................................320
Listing 16.2.5.5: Dosing Deviations ............................................................................................321
Listing 16.2.6.1: Investigator Global Assessment (IGA) ............................................................322
Listing 16.2.6.2: Body Surface Area (BSA) Involved with Psoriasis .........................................323
Listing 16.2.6.3: Psoriasis Area and Severity Index (PASI)........................................................324
Listing 16.2.6.7: Columbia-Suicide Severity Rating Scale (C-SSRS) ........................................325
Listing 16.2.6.8.1: Patient Health Questionnaire Depression Scale (PHQ-8) Question 
Descriptions ........................................................................................326
Listing 16.2.6.8.2: Patient Health Questionnaire Depression Scale (PHQ-8) .............................327
Listing 16.2.7.1.1: Investigator Local Tolerability Assessment ..................................................328
Listing 16.2.7.2.1: Unique Adverse Events Coded to MedDRA System Organ Classes and 
Preferred Terms ...................................................................................329
Listing 16.2.7.2.2: Treatment-Emergent Adverse Events ............................................................330


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Listing 16.2.7.2.3: Serious Adverse Events .................................................................................331
Listing 16.2.7.2.4: Subjects Who Permanently Discontinued Study Drug Due to Adverse 
Events ..................................................................................................332
or Exeprienced an Adverse Event Resulting in Death .................................................................332
Listing 16.2.8.1: Urine Pregnancy Test Results ..........................................................................333
Listing 16.2.8.2: 12-lead Electrocardiogram Test Results ...........................................................334
Listing 16.2.8.3.1: Vital Signs .....................................................................................................335
Listing 16.2.8.3.2: Weight Loss/Gain >5% .................................................................................336


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Listing 16.2.1.1: End of Study Information
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                   
                              
S: Subject                          
 
                               
A: Age/Sex         F: Date of First Dose of Drug   Primary Reason for Study                          
E: Eval            L: Date of Last Dose of Drug    Completion/Discontinuation                Date of Completion/Discontinuation
______________________________________________________________________________________________________________________________________
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxxx xx xxxxxxxxxxxxxxx             xxxxxxxxxx xxxx 
A: xxxx            L: xxxxxxxxxx                                              
E: xxxxxxxxx                    
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxxx xx xxxxxxxxxxxxxxx             xxxxxxxxxx xxxx          
A: xxxx
        L: xxxxxxxxxx                                            
E: xxxxxxxxx                    
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxx xxxx xxxxxxxx xxxxx             xxxxxxxxxx xxxx                 
A: xxxx          
L: xxxxxxxxxx                                                   
E: xxxxxxxxx                    
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.1.2: Discontinued Subjects
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                   
                              
S: Subject                         
                               
A: Age/Sex        F: Date of First Dose of Drug   Primary Reason for Study                          
E: Eval            L: Date of Last Dose of Drug    Completion/Discontinuation                Date of Completion/Discontinuation
______________________________________________________________________________________________________________________________________
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxxx xx xxxxxxxxxxxxxxx             xxxxxxxxxx xxxx 
A: xxxx
         L: xxxxxxxxxx
E: xxxxxxxxx                    
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxxx xx xxxxxxxxxxxxxxx             xxxxxxxxxx xxxx          
A: xxxx            L: xxxxxxxxxx
E: xxxxxxxxx
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxx xxxx xxxxxxxx xxxxx             xxxxxxxxxx xxxx                 
A: xxxx            L: xxxxxxxxxx        
E: xxxxxxxxx                    
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.2.1: Inclusion/Exclusion Criteria Violations
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                Criterion    Criterion
Subject   Age/Sex  Eval         Category     Identifier   Description
______________________________________________________________________________________________________________________________________
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxx
                                                          xxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx xx xxx xxxxxxxxx xxx xxxxxxxx xxxx
xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxxxx                       
                                                          x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx xxxxxxxxx xxx xxxxxxxx xxxxxx xxxxxxx x
                                                          xxxxxxxxx xxxxx xxx
                                xxxxxxxxx        xx       xxxxxxxx xxxx xxxxxx xxxx xxxxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxx 
                                                          xxxxxxxx xxxxx xx xxxx xxxx xx xxx xx xxxx xxxx xxx xxxxx xxxxx
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx 
                                              
                                xxxxxxxxx        xx       xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxxxxx
                                                          xxx xxxxx xxxxxxxxx xxxx
                                 
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.2.2: Protocol Deviations
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
Subject   Age/Sex  Eval         Protocol Deviation 
______________________________________________________________________________________________________________________________________
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx
                                xxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx xx xxx  
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
                                xxxxxxxxx xxxxx xxx
                                xxxxxxxx xxxx xxxxxx xxxx xxxxxxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
                                xxxxxxxx xxxx xxxxxx xxxx xxxxxxx 
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.3: Analysis Populations
Treatment Group
(Page xx of yy) 
______________________________________________________________________________________________________________________________________
Subject   Age/Sex     Population          Included           Reason(s) Excluded                                   
______________________________________________________________________________________________________________________________________
xxxxxx    xxxx        Safety                 xx              xxxxxxx x xxxxxx xxxxxxxxx
xxxxxx    xxxx        Safety     
xxx
xxxxxx    xxxx        Safety                 xxx
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.1: Subject Demographic Information
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                       
                                                                                                            
                                      D: Date/Time of                               C: Childbearing            
                    B: Date of Birth     Informed Consent     R: Race                  Potential
Subject  Eval       S: Sex         
A: Age at Consent       E: Ethnicity     
B: Birth Control Method
______________________________________________________________________________________________________________________________________
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx xx xxxxxxx   C: xx                   
                    S: xxxx           A: xx                   E: xxx xxxxxxxx xx    B:
                                                        
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx              C: xxx                 
                    S: xxxxxx         A: xx                   E: xxx xxxxxxxx xx    B: xxxxxxxxxx xxxxxxxx
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx              C: xxx                  
                    S: xxxxxx         A: xx                   E: xxx xxxxxxxx xx    B: xxxx xxxxxxxxxxxxxx
                                                  
  
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes and Preferred Terms
(Page xx of yy)
______________________________________________________________________________________________________________________________________
MedDRA System Organ Class                     MedDRA Preferred Term                       Condition/Surgery Verbatim Term
______________________________________________________________________________________________________________________________________
x xxx xxxxx                                   xxxx xxx xxxxx                              xxxx xxxxxxxxxx xx xxxxxx 
                                                                                        
                                                                                          xxxxx xxx xxxxxx xx
                                                                                         
xxxx x xxxxxxxxx                              xxxxxxx xxxxxxxxxxxxx                       xxxx xxxxxx xxxxxxxxxx xx xxxxxx
xxxx xxx xxxxx                                xxxx xxx xxxxx                              xxxx xxxxxxxx
                                                                                          xxxxxx xxxxxxxxxx xx xxxxxx
                                                                                          xxxxxx xxxxxxxxxx xx xxxxx
                                                                                          
______________________________________________________________________________________________________________________________________
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.2.2: Medical/Surgical History
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________       
                                                                                                       
 
                                   Condition/Surgery
P: MedDRA Preferred Term             
S: Onset Date
Subject    Age/Sex    Eval         Verbatim Term                 
S: MedDRA System Organ Class        
E: End Date
______________________________________________________________________________________________________________________________________
xxxxxx     xxxx       xxxxxxxx     xxxxxx xxxxxxx (xxxxxxxx xxxxx) 
P: xxxxxx xxxxxxxxxx
S: xxxxxxxxxxx
                                                                   
S: xxxxxxxxxxx xxxxxxx
E: xxxxxxxxxxx
 
 
 
 
 
 
 
 
  
                                   xxxxxxxx xxxxxxxxxx
P: xxxxxxx xxxxxxxx
S: xxxxxxxxxxx
                                                                   
S: xxxxxx xxxxxxxxxxxxx              
E: xxxxxxxxxxx
 
 
 
 
  
______________________________________________________________________________________________________________________________________
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.3.1: Unique Medication Names Coded to WHO-DD ATC Level 2 Terms and Preferred Names
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                                                                             I: Indication
ATC Level 2 Term                 Preferred Name                         Medication Name                      R: Route
______________________________________________________________________________________________________________________________________
xxxxxx xxxxxx xx xxx             xxxxxxxxxx                             xxxxxxxxxx                         
I: xxxxxxx xxxxxxxx
                                                                                                             R: xxxx
                                 xxxxxxx x                              xxxxxx                               I: xxxxxxx xxxxxxxx
                                                                                                                xxxxxxxxxxxx
                                                                                                             R: xxxx
                                 xxxxxxxxx                              xxxxxxxxx                            I: xxxxxxx xxxxxxxx xxxx
                                                                                                                xxxxx xxxxxxxx
                                                                                                             R: xxxx
______________________________________________________________________________________________________________________________________
Note: Preferred Name and ATC Level 2 Term map to the WHO-DD (Version March 1, 2018).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.3.2: Prior and Concomitant Medications
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                      M: Medication Name                                                    D: Dose                 
                                      P: Preferred Name                            F: Date of First Dose    U: Units          
                                      A: ATC Level 2 Term                          S: Start Date (Day)¹     F: Frequency         
Subject     Age/Sex    Eval           I: Indication                                E: End Date (Day)¹       R: Route  
______________________________________________________________________________________________________________________________________
xxxxxx      xxxx       xxxxxxxxxx     M: xxxxxxxxxxxxx                             F: xxxxxxxxxx            D: xx              
                                      P: xxxxxxxxxxxxx                             S: xxxxxxxxxx            U: xx             
                                      A: xxxxxxxxxxxxx                             E: xxxxxxxxxx            F: xxxx
                                      I: xxxxxxxx                                                           R:xxxx
                                                                                                              
                                      M: xxxxxxxxxxxxx                 
F: xxxxxxxxxx            D: xxxxx
                                      P: xxxxxxxxxxxxx                             S: xxxxxxxxxx            U: xx            
                                      A: xxxxxxxxxxxxx                             E: xxxxxxxxxx            F: xx
                                      I: xxxxxxxx                                                           R:xxxx
                                                                                                              
xxxxxx      xxxx       xxxxxxxxxx     M: xxxxxxxxxxxxx                             F: xxxxxxxxxx            D: xxx             
                                      P: xxxxxxxxxxxxx                             S: xxxxxxxxxx            U: xx
                                      A: xxxxxxxxxxxxx                             E: xxxxxxxxxx            F: xx
                                      I: xxxxxxxx
R:xxxx
                                                                                                        
______________________________________________________________________________________________________________________________________
¹ Day is calculated as date – date of first dose for dates prior to first dose. Otherwise, day is calculated as date – date of first
dose + 1 for dates on or after first dose.
Note: Preferred Name and ATC Level 2 Term map to the WHO-DD (Version March 1, 2018).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.4.1: Unique Therapies and Procedures Coded to MedDRA System Organ Classes and Preferred Terms
(Page xx of yy)
______________________________________________________________________________________________________________________________________
MedDRA System Organ Class                     MedDRA Preferred Term                       Procedure/Therapy Verbatim Term 
______________________________________________________________________________________________________________________________________
xxxx xxx xxxxx                                xxxx xxx xxxxx                              xxxx
                                                                                          xxxxxx xxxxxxxxxx xx xxxxxx
                                                                                          xxxxxx xxxxxxxxxx xx xxxxx
xxxx xxx xxxxx                          
xxxx xxx xxxxx                              xxxx
                                                                                          xxxxxx xxxxxxxxxx xx xxxxxx
xxxxxx xxxxxxxxxx xx xxxxx
______________________________________________________________________________________________________________________________________
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.4.2: Prior and Concomitant Therapies and Procedures
(Page xx of yy)
______________________________________________________________________________________________________________________________________
S: Subject
A: Age/Sex                                        I: Indication            P: MedDRA Preferred Term              S: Start Date
E: Eval       Procedure/Therapy Verbatim Term     A: Anatomical Area       S: MedDRA System Organ Class          E: End Date
______________________________________________________________________________________________________________________________________
S: xxxxxx     xxxxxx xxxxxxx (xxxxxxxx xxxxx)     I: xxxxxxxxxx            P: xxxxxx xxxxxxxxxx              
S: xxxxxxxxxxx
A: xxxx                                           A: xxxx                  S: xxxxxxxxxxx xxxxxxx            
E: xxxxxxxxxxx
E: xxxxxxxx
xxxxxx xxxxxxx xxxxxxx              I: xxxxxxxxxx xxxxx      P: xxxxxx xxxxxxxxxx              
S: xxxxxxxxxxx
                                                  A:                       S: xxxxxxxxxxx xxxxxxx            
E: xxxxxxxxxxx
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
S: xxxxxx     xxxxxx xxxxxxxxxxxxxx               I: xxxxxxxxxx xxxxx      P: xxxxxx xxxxxxxxxx              
S: xxxxxxxxxxx
A: xxxx                                           A: xxxx xxx xxxxx        S: xxxxxxxxxxx xxxxxxx
E: xxxxxxxxxxx
E: xxxxxxxx
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
                   
______________________________________________________________________________________________________________________________________
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.4.5: Physical Examination
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                
S: Subject         
                               
A: Age/Sex
                    
Abnormal Finding                       
E: Eval         Visit             Date        
Body System Assessed            Finding                     Specification
______________________________________________________________________________________________________________________________________
S: xxxxxx       xxxxxxxxxxx       xxxxxxxxxx       Heart                            xxxxxxxxxx                 xxxxxxx xxxxx 
A: xxxx                                            Lungs                            xxxxx xxxxxxx
E: xxxxxxxxx                                       Skin (Other than Psoriasis)      xxxxxxxx
                                                   <Other, specify>                 xxxx xxx xx                xxxxxxxxxxx xxx xxxxxx
                xxxxxxxxxxx       xxxxxxxxxx       Heart                            xxxxxxxx
                                                   Lungs                            xxxxx xxxxxxx
                                                   Skin (Other than Psoriasis)      xxxxxxxx
                xxxx xx           xxxxxxxxxx       Heart                            xxxxxxxx
                                                   Lungs                            xxxxx xxxxxxx
                                                   Skin (Other than Psoriasis)      xxxxxxxx
S: xxxxxx       xxxxxxxxxxx       xxxxxxxxxx       Heart                            xxxxxxxxxx
A: xxxx                            
Lungs                            xxxxxxxxx  xx              xxxxxx
E: xxxxxxxxx                                       Skin (Other than Psoriasis)      xxxx xxxxxxxx
                xxxxxxxxxxx       xxxxxxxxxx       Heart
xxxxxx xxxxx                           
Lungs                            xxxxxxx                           
Skin (Other than Psoriasis)
xxxxxxxxxx
xxxx xx           xxxxxxxxxx       Heart                            xxxxxxxx                 
Lungs                            xxxxx xxxxxxx
Skin (Other than Psoriasis)      xxxxxxxx                           
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.5.1: Study Visit Compliance
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                                                                                        
                                                                             Study          Within Visit     Days Out of
Reason
Subject    Age/Sex    Eval 
Visit
Visit Date                 Day¹           Window           Window²    
Not Done
______________________________________________________________________________________________________________________________________
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx     xxxxxxxxxx                 x              xxx                           xxxxxxx
xxxxxxxx
xxxxxxxxxx                 x              xxx
xxxx x        xxxxxxxxxx                 xx             xxx              xxxx
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx     xxxxxxxxxx to xxxxxxxxxx   x              xxx
                                    xxxxxxxx      xxxxxxxxxx                 x              xxx
                                    xxxx x        xxxxxxxxxx                 xx             xxx                           xxxxxxxxx xx
                                    xxxx x        xxxxxxxxxx                 xx             xxx
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx     xxxxxxxxxx                 xx             xxx
                                    xxxxxxxx      xxxxxxxxxx                 x              xxx 
                                    xxxx x        xxxxxxxxxx                 xx             xxx
______________________________________________________________________________________________________________________________________
¹ Day is calculated as date – baseline date for dates prior to baseline visit. Otherwise, day is calculated as  
date – baseline date + 1 for dates on or after baseline visit.
² Populated only for post baseline visits that are planned and out of window.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.5.2: Drug Accountability
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                  Date              Date                         Dispensed         Returned
Subject    Age/Sex    Evaluable    Kit Number     Dispensed         Returned      Tube ID        Weight (g)        Weight (g)
______________________________________________________________________________________________________________________________________
xxxxxx     xxxx       xxxxxxxx     xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                   xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                   xxxxx
xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
xxxxxx     xxxx       xxxxxxxx     xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x
                                                                                    x            xx.x              xx.x
                                                                                    x            xx.x              xx.x
x            xx.x              xx.x
xxxxx
xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x
x            xx.x              xx.x
x            xx.x              xx.x
x            xx.x              xx.x
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.5.3: Study Drug Application
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                   Date/Time of Study     Study Drug           Pre-Dose     Post-Dose     Reason
Subject    Age/Sex    Evaluable    Visit           Drug Application       Applied in Clinic?   Weight (g)   Weight (g)    Not Done
______________________________________________________________________________________________________________________________________
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
xxxxx           xxxxxTxxxx                 xxx
xx.x          xx.x 
xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xx                                    
xxx xxx xxxxx
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xx                                         xxx xxx xxxxx
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x 
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.5.4: Dosing Compliance
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
S: Subject                            
Number of    Calculated¹    Amount of     Maximum Number                                                       
A: Age/Sex     D: Date of First Dose     Days of      Number of    Study Drug       of Missed            Percent             
E: Eval        R: Date of Last Dose      Exposure       Doses       Used (g)     Consecutive Doses      Compliant    Compliant?²    
______________________________________________________________________________________________________________________________________
S: xxxxxx      D: xxxxxxxxxxxx             xx            xx           xxxx              x                  xxx          xxx
A: xxxx        R: xxxxxxxxxxxx
E: xxxxxxxxx                    
S: xxxxxx      D: xxxxxxxxxxxx             xx            xx           xxxx              x                  xxx           xx                            
A: xxxx        R: xxxxxxxxxxxx
E: xxxxxxxxx                    
S: xxxxxx      D: xxxxxxxxxxxx             xx            xx           xxxx                                 xxxx          xxx 
A: xxxx        R: xxxxxxxxxxxx  
E: xxxxxxxxx                    
______________________________________________________________________________________________________________________________________
¹ The total number of doses was calculated from the date of first dose and the date of last known dose minus the missed doses plus
additional dose deviations.
² A subject was considered compliant with the dosing regimen if the subject applied at least 80% of the expected doses during the 
study drug application period and did not miss more than 3 consecutive doses.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


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Listing 16.2.5.5: Dosing Deviations
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                            
Subject     Age/Sex     Eval          Date of First Dose       Date of Dosing Deviation
Number of Doses Applied
______________________________________________________________________________________________________________________________________
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx               xxxxxxxxxx
                           x 
xxxxxxxxxx                                     x
xxxxxxxxxx                                     x
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx               xxxxxxxxxx                                     x
                                                               xxxxxxxxxx                                     x
xxxxxx      xxxx    
xxxxxxxxx     xxxxxxxxxx               xxxxxxxxxx                                     x
                                                               xxxxxxxxxx                                     x
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 322 of 337
CONFIDENTIAL
Listing 16.2.6.1: Investigator Global Assessment (IGA)
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________                 
                                                                                             
S: Subject                                   Whole Body            Does the Subject        Intertriginous 
Was
A: Age/Sex                 Date of          Investigator Global   have Intertriginous     Investigator Global    Evaluator Dosing
E: Eval         Visit       Assessment       Assessment Score      Area involvement?       Assessment Score      Initials
Stopped
______________________________________________________________________________________________________________________________________
S: xxxxxx       SCREENING   xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx           xxx
A: xxxx
E: xxxxxxxx
                BASELINE    xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx            xxx
                WEEK 2
xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx            xxx                                
                WEEK 4      xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx            xxx               
                WEEK 6      xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx            xxx
                WEEK 8      xxxxxxxxxx       x x xxxxxxxx           xx                                              xxx 
                WEEK 12     xxxxxxxxxx       x x xxxxxxxx           xx                                              xxx
xxx
                WEEK 16     xxxxxxxxxx       x x xxxxxxxx           xx                                              xxx
S: xxxxxx       SCREENING   xxxxxxxxxx       x x xxxxxxxx           xx                                              x- x                                
A: xxxx
E: xxxxxxxx
                BASELINE    xxxxxxxxxx       x x xxxxxxxx           xx
x-x
WEEK 2      xxxxxxxxxx       x x xxxxxxxx           xx                                              x- x                                
                WEEK 4      xxxxxxxxxx       x x xxxxxxxx           xx                                              x-x
WEEK 6      xxxxxxxxxx       x x xxxxxxxx           xx                                              xxx
WEEK 8      xxxxxxxxxx
x x xxxxxxxx           xx                                              xxx  
WEEK 12     xxxxxxxxxx       x x xxxxxxxx           xx                                              xxx
xx
WEEK 16     xxxxxxxxxx       x x xxxxxxxx           xx                                              xxx        xxx
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 323 of 337
CONFIDENTIAL
Listing 16.2.6.2: Body Surface Area (BSA) Involved with Psoriasis
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
Subject   Age/Sex  Eval       Visit
Date of Assessment          
BSA¹ (%)                     Evaluator Initials
______________________________________________________________________________________________________________________________________
xxxxxxxx  xxxx     xxxxxxxxx   xxxxxxx           xxxxxxxxxx       
xx.x                             xxx
                               xxxxxxxxx         xxxxxxxxxx                      xx.x                             xxx
                               xxxx x            xxxxxxxxxx                      xx.x 
xxx
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx
                               xxxx x            xxxxxxxxxx                      xx.x                     
xxx
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx
                               xxxx xx           xxxxxxxxxx                      xx.x                             xxx
xxxxxxxx  xxxx     xxxxxxxxx   xxxxxxx           xxxxxxxxxx                      xx.x                             xxx
                               xxxxxxxxx         xxxxxxxxxx                      xx.x                             xxx
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx
xxxx x
xxxxxxxxxx                      xx.x                             xxx
xxxx x            xxxxxxxxxx                      xx.x                             xxx
xxxx xx           xxxxxxxxxx                      xx.x                             xxx
______________________________________________________________________________________________________________________________________
¹ Body Surface Area (BSA) involved with psoriasis (excluding the scalp, palms and soles).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 324 of 337
CONFIDENTIAL
Listing 16.2.6.3: Psoriasis Area and Severity Index (PASI)
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
V: Visit
                                                                                                  
S: Subject      D: Date                                                                      
A: Age/Sex      E: Evaluator
P: PASI
Affected Area 
___________________________Parameter Score___________________________
E: Eval           Initials     M: mPASI     (% Involved) 
Erythema (redness)    Induration (thickness)   Desquamation (scaling)      
______________________________________________________________________________________________________________________________________
S: xxxxxx       V: SCREENING    P: xx.x      Arms (xx-xx%)
x - xxxxxxx xxxxxxxx  x - xxxxxxx xxxxxxxx     x - xxxxxxx xxxxxxxx                   
A: xxxx         D: xxxxxxxxxx   M: x.x                                                                                                                 
E: xxxxxxxxx    E: xxx      
                                             Head (xx-xx%)
x - xxxxxxx xxxxxxxx  x - xxxxxxx xxxxxxxx     x - xxxxxxx xxxxxxxx  
                                             Legs (xx-xx%)
x - xxxx              x - xxxx                 x
                                             Trunk(x%)
      x - xxxx              x - xxxx                 x
                V: BASELINE     P: x.x       Arms (x%)
x                     x                        x                                      
                D: xxxxxxxxxx
M: x.x                                                                                                                 
                E: xxx
                                             Head (x%)
x - xxxxxxx xxxxxxxx  x - xxxxxxx xxxxxxxx     x - xxxxxxx xxxxxxxx                   
                                             Legs (xx–xx%)
x - xxxx              x - xxxx                 x
                                             Trunk(xx–xx%)
x - xxxx              x - xxxx                 x
                V: WEEK 2       P: x.x
Arms (xx–xx%)
x                     x                        x                                      
                D: xxxxxxxxxx
M: x.x
                E: xxx
                                             Head (xx–xx%)       x                     x
x                                      
                                             Legs (xx–xx%)
x - xxxx              x - xxxx                 x - xxxx
                                             Trunk (xx–xx%)
x - xxxx
x - xxxx                 x - xxxx
                V: WEEK 6       P: x.x
  Arms (xx–xx%)
x - xxxx              x - xxxx                 x                                      
D: xxxxxxxxxx   M: x.x
                E: xxx
                                             Head (xx–xx%)
x - xxxx              x                        x - xxxx                 
Legs (x.x%)         x - xxxx              x - xxxx                 x - xxxx
                                             Trunk(xx–xx%)
x - xxxx              x - xxxx                 x - xxxx
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 325 of 337
CONFIDENTIAL
Listing 16.2.6.7: Columbia-Suicide Severity Rating Scale (C-SSRS)
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                
S: Subject                         
A: Age/Sex     V: Visit
E: Eval        D: Date          Question                                         Time Period       Response          
______________________________________________________________________________________________________________________________________
S: xxxxxx      V: SCREENING     xxxx xx xx xxxx                                  xxxxxxxx          xx
A: xxxx        D: xxxxxxxxxx                                                     xxxx x xxxxxx     xxx xxxx
E: xxxxxxxxx    
                                xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx  
xxxxxxxx          xxx
                                                                                                                     
                                                                                 xxxx x xxxxxx     xx
                                xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx               xxxxxxxx          xx
                                xxx xxxx xxxxxxxx xxxxx xx xxx                   xxxx x xxxxxx     xx
                                xxxxxx xxxxxxx xxxxxxx xxxx xxxxx                xxxxxxxx          xx
                                xx xxx xxxxxxx xxxxxxx xxxx                      xxxx x xxxxxx     xx
                                xxxxxx xxxxxxx xxxxxxx xxxx xxxxx                xxxxxxxx          xxx                   
                                xxxx xxx xxxxxx                                  xxxx x xxxxxx     xx 
                                xxxx xxxxxx xxxxxxx                              xxxxxxxx
x
                                                                                                             
xxxx x xxxxxx     xxx xxxx
xxx xxxx xxxxx xxxx xxxx xxxx xxxx               xxxxxxxx          x xxx xxxx
xxxx x xxxxxx     xxx xxxx
xxxx xx xxx xxxx xxxxx xxxxxxx                   xxxxxxxx          x x xxx xx xx
                                xxx xxx xxxx xx xxxx xxxx                        xxxx x xxxxxx     xxx xxxx                            
                                xxxxxxx xxxxxxx                                  xxxxxxxx          xx
                                                                                 xxxx x xxxxxx     xxx xxxx
                                xxx xxxxxxx xxxxxx xx xxx xxxxxx                 xxxxxxxx          xx
                                xxxxxxxxxxx xxxxxxxx                             xxxx x xxxxxx     xx
                                xxxxxxxxx xxxxxxx                                xxxxxxxx          xxx xxxxx
                                                                                 xxxx x xxxxxx     xxx xxxx
V: BASELINE      xxxx xx xx xxxx                                  xxxxx xxxx xxxxx  xx
D: xxxxxxxxxx 
                                                 
                                xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx               xxxxx xxxx xxxxx  xx                                                  
xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx               xxxxx xxxx xxxxx  xx
                                xxx xxxx xxxxxxxx xxxxx xx xxx                             
                                                                
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 326 of 337
CONFIDENTIAL
Listing 16.2.6.8.1: Patient Health Questionnaire Depression Scale (PHQ-8) Question Descriptions 
______________________________________________________________________________________________________________________________________
Number   PHQ-8 Question
______________________________________________________________________________________________________________________________________
1   How often during the past 2 weeks were you bothered by: Little interest or pleasure in doing things?
                                                                                                                          
2   How often during the past 2 weeks were you bothered by: Feeling down, depressed, or hopeless? 
3   How often during the past 2 weeks were you bothered by: Trouble falling or staying asleep, or sleeping too much?
4   How often during the past 2 weeks were you bothered by: Feeling tired or having little energy?
5   How often during the past 2 weeks were you bothered by: Poor appetite or overeating?
6   How often during the past 2 weeks were you bothered by: Feeling bad about yourself, or that you are a failure, or have let 
yourself or your family down?
7   How often during the past 2 weeks were you bothered by: Trouble concentrating on things, such as reading the newspaper or
watching television?
8   How often during the past 2 weeks were you bothered by: Moving or speaking so slowly that other people could have
noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual?
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 327 of 337
CONFIDENTIAL
Listing 16.2.6.8.2: Patient Health Questionnaire Depression Scale (PHQ-8)
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                                                 
                                                    Date of 
Subject    Age/Sex     Eval           Visit         Assessment        1      2      3      4      5      6      7      8   
______________________________________________________________________________________________________________________________________
xxxxxx     xxxx        xxxxxxxxx
xxxxxxxxx     xxxxxxxxxx
x      x      x      x      x      x      x      x   
                                      xxxxxxxx      xxxxxxxxxx
x      x      x      x      x      x      x      x      
                                      xxxx x        xxxxxxxxxx
x      x      x      x      x      x      x      x     
                                      xxxx x        xxxxxxxxxx
x      x      x      x      x      x      x      x     
                                      xxxx xx       xxxxxxxxxx
x      x      x      x      x      x      x      x    
xxxxxx     xxxx        xxxxxxxxx
xxxxxxxxx     xxxxxxxxxx
x      x      x      x      x      x      x      x   
                                      xxxxxxxx      xxxxxxxxxx
x      x      x      x      x      x      x      x      
                                      xxxx x        xxxxxxxxxx
x      x      x      x      x      x      x      x     
                                      xxxx x        xxxxxxxxxx
x      x      x      x      x      x      x      x     
                                      xxxx xx       xxxxxxxxxx
x      x      x      x      x      x      x      x    
xxxxxx     xxxx        xxxxxxxxx
xxxxxxxxx     xxxxxxxxxx
x      x      x      x      x      x      x      x   
                                      xxxxxxxx      xxxxxxxxxx
x
x      x      x      x      x      x      x
                                      xxxx x        xxxxxxxxxx
x      x      x      x      x      x      x      x     
                                      xxxx x        xxxxxxxxxx
x
x      x      x      x      x      x      x     
                                      xxxx xx       xxxxxxxxxx
x      x      x      x      x      x      x      x    
______________________________________________________________________________________________________________________________________
Note: For all Questions: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day, ND = Not Done.
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 328 of 337
CONFIDENTIAL
Listing 16.2.7.1.1: Investigator Local Tolerability Assessment
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
S: Subject      V: Visit                                                                                            
A: Age/Sex      D: Date                                          Other Effects  Other Effects                  Locations where Other                   
E: Eval         E: Evaluator Initials  Dermal Response           Assessed?      Present                        Effects are Present
______________________________________________________________________________________________________________________________________
S: xxxxxx       V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxxxxxxx                xxxx xxxxx
A: xxxx         D: xxxxxxxxxx xxxx                                              xxxxxx xxxx xxxxxxxx           xxxx xxxxx xxxx xxxx                    
E: xxxxxxxxx    E: xxx
                V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx           xxxx xxxxx xxxxxxx      
                D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx
                E: xxx 
  
                V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx           xxxx 
                D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx
                E: xxx 
                V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx
xxxx
                D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx
                E: xxx 
S: xxxxxx       V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxxxxxxx                xxxx xxxxx
A: xxxx         D: xxxxxxxxxx xxxx                                              xxxx xx xxxxx xxxx             xxxx                          
E: xxxxxxxxx    E: xxx                                                          xxxxxxx xxxx xxxxxxx           xxxx
V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx           xxxx 
D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx                                        
E: xxx 
                                                                          
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 329 of 337
CONFIDENTIAL
Listing 16.2.7.2.1: Unique Adverse Events Coded to MedDRA System Organ Classes and Preferred Terms
(Page xx of yy)
______________________________________________________________________________________________________________________________________
MedDRA System Organ Class                      MedDRA Preferred Term                       Adverse Event
______________________________________________________________________________________________________________________________________
xxxxx xxx xxxxxxxxx xxxxxx xxxxxxxxx           xxxxxxx                                     xxxxxx
xxxxxx
xxxxxxxxxxxx                                xxxxxxxxxxxx
xxx xxx xxxxxxxxx xxxxxxxxx                    xxxxxxx
xxxxxxx
xxx xxxxxxxxx                                  xxxxxx xxxxxx xxxxxxx                       xxxxxxxxx xxxxxx xxxxxx
xxxxxxxxxxxxxxxx xxxxxxxxx                     xxxxxxxxx xxxx                              xxxxxxxxx xxxx
                                               xxxxxxxxx xxxxxxxxxxxx                      xxxxx xxxxxxxxx xxxxxxxxxxxx
______________________________________________________________________________________________________________________________________
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 330 of 337
CONFIDENTIAL
Listing 16.2.7.2.2: Treatment-Emergent Adverse Events
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                                                   
                                                                                                     S: Serious Event?
                                                                         G: Grade2                   A: In Treatment Area?   
S: Subject         A: Adverse Event           F: Date of First Dose      R: Relationship to          T: Action Taken with    
A: Age/Sex         C: System Organ Class      S: Start Date (Day)¹          Study Drug                  Study Drug
E: Eval            P: Preferred Term          E: End Date (Day)1
O: Outcome                  E: Action Taken to Treat Event 
______________________________________________________________________________________________________________________________________
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xx
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx 
E: xxxxxxxxx
P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx
                                                                                                     E: xxxxxxx
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xx
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx 
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx   
T: xxx
                                                                                                     E: xxxxxxx
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xx
A: xxxx          
C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xx
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx
                                                                                                     E: xxxxxxx
  
______________________________________________________________________________________________________________________________________
¹ Day is calculated as date – date of first dose for dates prior to first dose.  Otherwise, day is calculated as
date – date of first dose + 1 for dates on or after first dose.
2 Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death.
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 331 of 337
CONFIDENTIAL
Listing 16.2.7.2.3: Serious Adverse Events
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                                                   
                                                                                                     S: Serious Evemt?
                                                                         G: Grade2                   A: In Treatment Area?   
S: Subject         A: Adverse Event           F: Date of First Dose      R: Relationship to          T: Action Taken with    
A: Age/Sex         C: System Organ Class      S: Start Date (Day)¹          Study Drug                  Study Drug
E: Eval
    P: Preferred Term          E: End Date (Day)1
O: Outcome                  E: Action Taken to Treat Event 
______________________________________________________________________________________________________________________________________
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xxx
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx 
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx  
E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx
                                                                                                     E: xxxxxxx
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xxx
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx 
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx
                                                                                                     E: xxxxxxx
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xxx
A: xxxx            C: xxxxxxxxxxxxxxx  
S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xx
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx
                                                                                                     E: xxxxxxx
  
______________________________________________________________________________________________________________________________________
¹ Day is calculated as date – date of first dose for dates prior to first dose.
Otherwise, day is calculated as
date – date of first dose + 1 for dates on or after first dose.
2 Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death.
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 332 of 337
CONFIDENTIAL
Listing 16.2.7.2.4: Subjects Who Permanently Discontinued Study Drug Due to Adverse Events
or Exeprienced an Adverse Event Resulting in Death
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                                               
S: Subject            R: Primary Reason for Study          ______________________________Adverse Events_______________________________
A: Age/Sex               Completion/Discontinuation                             
G: Grade²
E: Eval               S: Date of Study                     A: Adverse Event Description R: Relationship to
F: Date of First Dose    Completion/Discontinuation (Day)¹ C: System Organ Class           Study Drug             S: Start Date (Day)¹
L: Date of Last Dose  V: Last Visit Attended               P: Preferred Term            A: Action Taken           E: End Date (Day)¹
______________________________________________________________________________________________________________________________________
S: xxxxxx             R: xxxxxxx xxxxx                     A: xxxxxxxx xxx              G: xxxxx x                S: xxxxxxxxxx xxxx
A: xxxx               S: xxxxxxxxxx xxxx                   C: xxxxxxxxx xxxx            R: xxxxxxxxx              E: xxxxxxxxxx xxxx
E: xxxxxxxxx
V: xxxx x                            P: xxxxxxxxx xxxxxxx xxxx  
A: xxxxxxx xxxxxxxxx
F: xxxxxxxxxx                                                 xxxxxxxxx
xxxxxx
L: xxxxxxxxxx
______________________________________________________________________________________________________________________________________
¹ Day is calculated as date – date of first dose for dates prior to first dose.  Otherwise, day is calculated as
date – date of first dose + 1 for dates on or after first dose.
2 Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death.
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1).
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 333 of 337
CONFIDENTIAL
Listing 16.2.8.1: Urine Pregnancy Test Results
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
Subject     Age/Sex     Eval          Visit                    Date                             Result
______________________________________________________________________________________________________________________________________
xxxxxx      xxxx        xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                       xxxxxxxx
xxxxxxxx                 xxxxxxxxxx                       xxxxxxxx
xxxx x                   xxxxxxxxxx                       xxxxxxxx
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx
                                      xxxx xx 
xxxxxxxxxx                       xxxxxxxx
xxxxxx      xxxx        xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                       xxxxxxxx
                                      xxxxxxxx                 xxxxxxxxxx
xxxxxxxx
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx
                                      xxxx xx                  xxxxxxxxxx                       xxxxxxxx
xxxxxx      xxxx        xxxxxxxx      xxxxxxxxx                xxxxxxxxxx    
xxxxxxxx
                                      xxxxxxxx                 xxxxxxxxxx                       xxxxxxxx
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx
                                      xxxxxxxxx xx             xxxxxxxxxx                       xxxxxxxx
                                      xxxx xx                  xxxxxxxxxx                       xxxxxxxx
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 334 of 337
CONFIDENTIAL
Listing 16.2.8.2: 12-lead Electrocardiogram Test Results
Treatment Group
(Page x of xx)
_____________________________________________________________________________________________________________________________________
                                
                                    V: Visit
Subject      Age/Sex    Eval        D: Date/Time of ECG
ECG Parameter    Result (Units)
ECG Interpetation   Abnormal
_____________________________________________________________________________________________________________________________________
xxxxxxxxx    xxxx       xxxxxxxx    V: xxxxxxxxx               xxxxxxxxxx       xxxx xxxxx xx    xxxxxxxxxxxxxxxx
xxx - xxx  
                                    D: xxxx-xx-xxTxx:xx:xx     xxxxxxxxxx       xxxx xxxxx xx             
xxxxxxxxxx       xxxx xxxxx xx
xxxxxxxxxxxxxxxx
xxxxxx  
xxxxxxxxxx       xxxx xxxxx xx
xxxxxxxxxxxxxxxx
xxxxxxxxxx       xxxx xxxxx xx
xxxxxxxxxxxxxxxx
xxxxxxxxxx       xxxx xxxxx xx
xxxxxxxxxx       xxxx xxxxx xx
                                                              xxxxxxxxxx       xxxx xxxxx xx
                                    V: xxxxxxxxx               xxxxxxxxxx       xxxx xxxxx xx
                                    D: xxxx-xx-xxTxx:xx:xx     xxxxxxxxxx       xxxx xxxxx xx
                                                               xxxxxxxxxx       xxxx xxxxx xx
                                                               xxxxxxxxxx       xxxx xxxxx xx
  
                                                               xxxxxxxxxx       xxxx xxxxx xx             
                                                               xxxxxxxxxx       xxxx xxxxx xx             
                                                               xxxxxxxxxx       xxxx xxxxx xx
                                                              xxxxxxxxxx       xxxx xxxxx xx      
xxxxxxxxx    xxxx       xxxxxxxx    V: xxxxxxxxx               xxxxxxxxxx       xxxx xxxxx xx    xxxxxxxxxxxxxxxx     
                                    D: xxxx-xx-xxTxx:xx:xx
xxxxxxxxxx       xxxx xxxxx xx     xxxxxxxxxxxxxxxx
                                                               xxxxxxxxxx       xxxx xxxxx xx
xxxxxxxxxxxxxxxx
                                                               xxxxxxxxxx       xxxx xxxxx xx
                                                               xxxxxxxxxx       xxxx xxxxx xx
                                                               xxxxxxxxxx       xxxx xxxxx xx
                                                               xxxxxxxxxx       xxxx xxxxx xx
                                                              xxxxxxxxxx       xxxx xxxxx xx                       
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 335 of 337
CONFIDENTIAL
Listing 16.2.8.3.1: Vital Signs
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
Subject    Age/Sex    Eval         Visit            Date             Vital Sign                   Result          Units
______________________________________________________________________________________________________________________________________
xxxxxx     xxxx       xxxxxxxx     SCREENING        xxxxxxxxxx       Temperature                  xxxx            x
                                                                     Heart Rate                   xx              xxxxxxxxx
                                                                     Systolic Blood Pressure      xxx             xxxx
                                                                     Diastolic Blood Pressure     xx              xxxx
                                                                     Weight                       xxx             xx
                                   BASELINE         xxxxxxxxxx       Temperature                  xxxx            x
                                                                     Heart Rate                   xx              xxxxxxxxx
                                                                     Systolic Blood Pressure      xxx             xxxx
                                                                     Diastolic Blood Pressure     xx              xxxx
                                                                     Height                       xx              xx
                                                                     Weight                       xxx             xx
                                   xxxx x           xxxxxxxxxx       Temperature                  xxxx            x
                                                                     Heart Rate                   xx              xxxxxxxxx
                                                                     Systolic Blood Pressure      xxx             xxxx
                                                                     Diastolic Blood Pressure     xx              xxxx
                                                                     Weight                       xxx             xx
                                   xxxx x           xxxxxxxxxx       Temperature                  xxxx            x
                                                                     Heart Rate
xx              xxxxxxxxx
                                                                     Systolic Blood Pressure      xxx             xxxx
                                                                     Diastolic Blood Pressure     xx
xxxx
                                                                     Weight                       xxx             xx
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 336 of 337
CONFIDENTIAL
Listing 16.2.8.3.2: Weight Loss/Gain >5%
Treatment Group
(Page xx of yy)
______________________________________________________________________________________________________________________________________
                                                                                 Baseline     % Change
Subject    Age/Sex    Eval         Visit            Date             Weight(kg)  Weight(kg)  from Baseline
Reason
______________________________________________________________________________________________________________________________________
xxxxxx     xxxx
xxxxxxxx     xxxx x
xxxxxxxxxx
xxx         xxx
xxx         xxxx xxxxx xxxx xxx xx
                                                                                                              xxxxxxx xxxx xxxx xx xx
xxxx x
xxxxxxxxxx         xxx         xxx            xxx         xxxx xxx xxxx xxx xxxxxx
                                                                                                              x xxxxxx xxxx xxxx xxxx
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)


TOOL.AN.10-01.01 Statistical Analysis Plan Template
Page 337 of 337
CONFIDENTIAL






ELECTRONIC RECORD AND SIGNATURE DISCLOSURE  
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procedure described below. 
 
Withdrawing your consent  
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All notices and disclosures will be sent to you electronically  


Unless you tell us otherwise in accordance with the procedures described herein, we will provide 
electronically to you through the DocuSign system all required notices, disclosures, 
authorizations, acknowledgements, and other documents that are required to be provided or made 
available to you during the course of our relationship with you. To reduce the chance of you 
inadvertently not receiving any notice or disclosure, we prefer to provide all of the required 
notices and disclosures to you by the same method and to the same address that you have given 
us. Thus, you can receive all the disclosures and notices electronically or in paper format through 
the paper mail delivery system. If you do not agree with this process, please let us know as 
described below. Please also see the paragraph immediately above that describes the 
consequences of your electing not to receive delivery of the notices and disclosures 
electronically from us. 
 
How to contact Abond CRO:  
You may contact us to let us know of your changes as to how we may contact you electronically, 
to request paper copies of certain information from us, and to withdraw your prior consent to 
receive notices and disclosures electronically as follows: 
To contact us by phone call: 616-892-3704 
To contact us by email send messages to: helpdesk@abondcro.com 
 
To advise Abond CRO of your new email address  
To let us know of a change in your email address where we should send notices and disclosures 
electronically to you, you must send an email message to us at HelpDesk@abondcro.com and in 
the body of such request you must state: your previous email address, your new email 
address.  We do not require any other information from you to change your email address.  
If you created a DocuSign account, you may update it with your new email address through your 
account preferences.  
 
To request paper copies from Abond CRO  
To request delivery from us of paper copies of the notices and disclosures previously provided 
by us to you electronically, you must send us an email to jproos@abondcro.com and in the body 
of such request you must state your email address, full name, mailing address, and telephone 
number. We will bill you for any fees at that time, if any. 
 
To withdraw your consent with Abond CRO  
To inform us that you no longer wish to receive future notices and disclosures in electronic 
format you may: 


i. decline to sign a document from within your signing session, and on the subsequent page, 
select the check-box indicating you wish to withdraw your consent, or you may; 
ii. send us an email to helpdesk@abondcro.com and in the body of such request you must state 
your email, full name, mailing address, and telephone number. We do not need any other 
information from you to withdraw consent..  The consequences of your withdrawing consent for 
online documents will be that transactions may take a longer time to process.. 
 
Required hardware and software  
The minimum system requirements for using the DocuSign system may change over time. The 
current system requirements are found here: https://support.docusign.com/guides/signer-guide-
signing-system-requirements.  
 
Acknowledging your access and consent to receive and sign documents electronically  
To confirm to us that you can access this information electronically, which will be similar to 
other electronic notices and disclosures that we will provide to you, please confirm that you have 
read this ERSD, and (i) that you are able to print on paper or electronically save this ERSD for 
your future reference and access; or (ii) that you are able to email this ERSD to an email address 
where you will be able to print on paper or save it for your future reference and access. Further, 
if you consent to receiving notices and disclosures exclusively in electronic format as described 
herein, then select the check-
 
By selecting the check-
that: 
You can access and read this Electronic Record and Signature Disclosure; and 
You can print on paper this Electronic Record and Signature Disclosure, or save or send 
this Electronic Record and Disclosure to a location where you can print it, for future 
reference and access; and 
Until or unless you notify Abond CRO as described above, you consent to receive 
exclusively through electronic means all notices, disclosures, authorizations, 
acknowledgements, and other documents that are required to be provided or made 
available to you by Abond CRO during the course of your relationship with Abond CRO.