Clinical trial NCT03004469
Conditions: Alopecia, Androgenetic
Sponsor: Polichem S.A.
Start date: 2016-08-02; Completion date: 2018-03-05
Enrollment: 458 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in participants with androgenetic alopecia.

Detailed description:

Arms: arm 1: Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 milligram (mg) tablet orally once daily for 24 weeks. arm 2: Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks. arm 3: Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Interventions: intervention 1: P-3074 intervention 2: Finasteride intervention 3: P-3074 Vehicle intervention 4: Finasteride Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
SAP_002.pdf: 
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Overall Preface  
Tables, Figures and Listings 
 
 
 
@ 
Patient Excluded from Safety Population 
 
 
$ 
Patient Excluded from Intent-to-Treat Population (ITT) 
 
 
& 
Patient Excluded from Per-Protocol Population 
 
 
(R) 
Repeat Visit 
 
 
(W) 
Patient Withdrew 
 
 
(M) 
Patient Misrandomized 
 
 
NA 
Not Applicable 
 
 
NC 
Not Calculated 
 
 
ND 
Not Done 
 
 
NK 
Not Known 
 
 
NR 
Not Recorded 
 
 
 
 
Program Name:                                  Date Generated:                                               Page x of y
 


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Table 14.1.1 
Summary of Disposition of Patients Overall 
 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total    
____________________________________________________________________________________________________________________________________ 
Patients with Informed Consent 
Patients Screened 
                                                     xxx 
                                                     xxx 
Patients Randomized  
xxx                xxx              xxx              xxx             
Safety Population  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
ITT Population  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
Per Protocol Population  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
 
Completed Study  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
 
Primary Reason for Early Discontinuation: 
 
  Adverse Event 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Death 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Lack of Efficacy 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Lost to Follow-Up 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Non-Compliance with Study Drug 
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Physician Decision 
  
 
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Protocol Deviation 
  
 
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Study Terminated by Sponsor   
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Site Terminated by Sponsor   
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Technical Problems 
  
 
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Withdrawal by Patient 
  
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Other   
 
 
 
 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients in the All Randomized Population for each treatment group. 
Programming Notes: 
 
Obtain reasons for early discontinuation from CRF. Counts for screened patients will only be presented in the total column. 
Program Name:                                  Date Generated:                                               Page x of y 
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Table 14.1.2 
Disposition of Patients by Country and Trial Site 
Randomized Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
German 
  Site 1 name 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Site 2 name 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Site 3 name 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  … 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Total 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Grouped sites: xxx, yyy, zzz 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Hungary 
  Site 1 name 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Site 2 name 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Site 3 name 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  … 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Total 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
 
____________________________________________________________________________________________________________________________________ 
Note: Sites with less than 8 patients who are randomized within the same country will be grouped as one big site for analysis to ensure model 
converging. If the combined group is still less than 8 patients, it will then be grouped to the site with minimum number of patients 
randomized in the neighboring country. 
Programming Notes: 
 
Only include "Grouped site" if number of patient in each individual site is less than 8 and grouping is required for modelling. 
Program Name:                                  Date Generated:                                               Page x of y 


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Table 14.1.3 
Summary of Protocol Violations  
Randomized Population 
____________________________________________________________________________________________________________________________________ 
Protocol Violation 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Patients with at Least 1 Major Protocol Violation 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Major Protocol Violation 1 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
  etc 
 
 
 
 
____________________________________________________________________________________________________________________________________ 
The violations and deviations were identified prior to data unblinding.  
Program Name:                                  Date Generated:                                               Page x of y 


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Table 14.1.4.1 
Summary of Demography 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Age (Years) [a] 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                xxx              xxx              xxx             
xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
xx.x               xx.x             xx.x             xx.xx  
xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
xx.x               xx.x             xx.x             xx.xx  
xx.x               xx.x             xx.x             xx.xx  
 
Height (cm) 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                xxx              xxx              xxx             
xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
xx.x               xx.x             xx.x             xx.xx  
xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
xx.x               xx.x             xx.x             xx.xx  
xx.x               xx.x             xx.x             xx.xx  
 
Weight (kg) 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                xxx              xxx              xxx             
xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
xx.x               xx.x             xx.x             xx.xx  
xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
xx.x               xx.x             xx.x             xx.xx  
xx.x               xx.x             xx.x             xx.xx  
 
____________________________________________________________________________________________________________________________________ 
Note: Denominators for percentages are based on the number of patients with non-missing data in each treatment group for the relevant variable. 
[a] Age is calculated as calendar years from birth to informed consent 
[b] Body Mass Index 
Program Name:                                  Date Generated:                                               Page x of y 
 


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Table 14.1.4.1 
Summary of Demography 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
BMI (kg/m2) [b] 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                xxx              xxx              xxx             
xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
xx.x               xx.x             xx.x             xx.xx  
xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
xx.x               xx.x             xx.x             xx.xx  
xx.x               xx.x             xx.x             xx.xx  
 
Race, n (%) 
 
n 
xxx                xxx              xxx              xxx             
 
Asian 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Black/African American 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Caucasian/White 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Native Hawaiian/Pacific Islander 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
American Indian/Alaska Native 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Other 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Ethnicity, n (%) 
 
n 
xxx                xxx              xxx              xxx             
 
Hispanic or Latino 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Not Hispanic or Latino 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Not Provided or Unknown 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
____________________________________________________________________________________________________________________________________ 
Note: Denominators for percentages are based on the number of patients with non-missing data in each treatment group for the relevant variable. 
[a] Age is calculated as calendar years from birth to informed consent 
[b] Body Mass Index 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Table 14.1.4.1 
Summary of Demography 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Current Alcohol Use, n(%) 
 
n 
xxx                xxx              xxx              xxx             
 
None 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Less Than or Equal to 2 Drinks  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Per Day 
 
More Than 2 Drinks Per Day 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Current Smoke/Tobacco Use, n (%) 
 
n 
xxx                xxx              xxx              xxx             
 
Never Smoked/Never Used Tobacco 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Products 
 
Currently Smokes/Uses Tobacco 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Products 
 
Formally Smoked/Used Tobacco 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    
Product 
 
Smoke >=10 Cigarettes/Day, n (%) 
 
n 
xxx                xxx              xxx              xxx             
 
Yes 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
No 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Drink > 5 Cup Coffee/Tea/Day, n (%) 
 
n 
xxx                xxx              xxx              xxx             
 
Yes 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
No 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
____________________________________________________________________________________________________________________________________ 
Note: Denominators for percentages are based on the number of patients with non-missing data in each treatment group for the relevant variable. 
[a] Age is calculated as calendar years from birth to informed consent 
[b] Body Mass Index 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.1.4.2 Summary of Demography Safety Population 
 
 


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Table 14.1.5.1 
Summary of Medical History 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
 P-3074 + P                Vehicle + P              Vehicle + FNS            Overall Total   
 (N = xxx)                  (N = xxx)                 (N = xxx)               (N = xxx) 
 n (%)/e (%)                n (%)/e (%)               n (%)/e (%)              n (%)/e (%) 
____________________________________________________________________________________________________________________________________ 
Vertex Pattern Hair Loss According to Norwood/Hamilton Scale 
  Type III Vertex 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Type IV 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Type V 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Other 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
 
Patients with Any Current Medical History?       
  No 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Yes 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
 
Medical History                                  
System Organ Class 1 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 1 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 2 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 3 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 4 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
 
System Organ Class 1 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  : 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  : 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
 
____________________________________________________________________________________________________________________________________ 
 
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
Note: This table contains counts of patients. If a patient had more than one medical history within a preferred term, the patient is counted only 
once within a preferred term. If a patient had more than one medical history within a system organ class, the patient is counted once for 
each preferred term and once for the system organ class. 
Note: MedDRA Version MAR16B2E used for coding. 
 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.1.5.2 Summary of Medical History Safety Population 
 
 
 
 


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Table 14.1.6.1 
Summary of Prior Medications 
ITT Population 
____________________________________________________________________________________________________________________________________ 
WHO ATC Level 2 (Therapeutic Class) 
   Generic Term ([a]) 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Patients with Any Prior Medication? 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
ATC Level 2 Term 1 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 1 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 2 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 3 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 4 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
ATC Level 2 Term 2 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 1 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 2 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 3 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 4 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients in the ITT Population for each treatment group. 
Note: Prior medications are defined as medications taken with a start and stop date prior to the first day of study treatment. 
Note: A patient may have taken more than one medication. Therefore, the sum of medication counts and percentages may not equal the total counts. 
If a patient had more than one medication in a category, the patient is counted once in that category. 
[a] WHO Drug Dictionary (Version MAR16B2E) was used for coding. 
 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.1.6.2 Summary of Prior Medications Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients in the Safety Population for each treatment group. 
 
  Delete:  
    Footnote: The denominator for percentages is the number of patients in the ITT Population for each treatment group. 
 
 
 


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Table 14.1.7.1 
Summary of Concomitant Medications 
ITT Population 
____________________________________________________________________________________________________________________________________ 
WHO ATC Level 2 (Therapeutic Class) 
   Generic Term ([a]) 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Patients with Any Concomitant Medication? 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
ATC Level 2 Term 1 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 1 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 2 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 3 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 4 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
ATC Level 2 Term 2 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 1 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 2 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 3 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Generic Medication 4 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients in the ITT Population for each treatment group. 
Note: Concomitant medications are defined as medications taken with a start date on or after the first dose date of treatment, or those with a 
start date before the first dose date of treatment and a stop date on or after the first dose date of treatment or ongoing at the end of 
the study period. 
Note: A patient may have taken more than one medication. Therefore, the sum of medication counts and percentages may not equal the total counts.  
If a patient had more than one medication in a category, the patient is counted once in that category. 
[a] WHO Drug Dictionary (Version MAR16B2E) was used for coding. 
 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.1.7.2 Summary of Concomitant Medications Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients in the Safety Population for each treatment group. 
 
  Delete:  
    Footnote: The denominator for percentages is the number of patients in the ITT Population for each treatment group. 
 
 
 


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Table 14.1.8.1 
Summary of Treatment Compliance 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
 P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
  (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Compliance Via Diary(%) 
 
Tablets Count 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
 
xxx                xxx              xxx              xxx             
 xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
 xx.x               xx.x             xx.x             xx.xx  
 xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
 xx.x               xx.x             xx.x             xx.xx  
 xx.x               xx.x             xx.x             xx.xx  
 
      <80% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
      80% to 120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
      >120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Actual spray count for those prescribed 
with 1 Spray 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
 
<repeat for 2 sprays, 3 sprays and 4 
sprays> 
 
 
xxx                xxx              xxx              xxx             
 xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
 xx.x               xx.x             xx.x             xx.xx  
 xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
 xx.x               xx.x             xx.x             xx.xx  
 xx.x               xx.x             xx.x             xx.xx  
 
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients with non-missing data in the ITT Population for each treatment group. 
Compliant is defined as percentage compliance between 80.0% and 120.0%, inclusive.  
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Table 14.1.8.1 
Summary of Treatment Compliance 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
 P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
  (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Spray Compliance 
Compliance among with those with 1 Spray prescribed 
 
      <80% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
      80% to 120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
      >120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
<repeat for 2 sprays, 3 sprays and 4 sprays> 
 
Compliance among with those with 1-4 Spray prescribed 
 
      <80% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
      80% to 120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
      >120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients with non-missing data in the ITT Population for each treatment group. 
Compliant is defined as percentage compliance between 80.0% and 120.0%, inclusive.  
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Table 14.1.8.1 
Summary of Treatment Compliance 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
 P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
  (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Compliance Via Drug Accountability(%) 
 
Tablets Count 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
 
xxx                xxx              xxx              xxx             
 xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
 xx.x               xx.x             xx.x             xx.xx  
 xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
 xx.x               xx.x             xx.x             xx.xx  
 xx.x               xx.x             xx.x             xx.xx  
 
    <80% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    80% to 120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    >120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Bottle Weight-1 Spray 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
 
<Repeat for Bottle Weight-2 Spray, 3 
sprays and 4 sprays> 
 
xxx                xxx              xxx              xxx             
 xx.x ( xx.xx)      xx.x ( xx.xx)    xx.xx ( xx.xx)   xx.xx ( xx.xx)       
 xx.x               xx.x             xx.x             xx.xx  
 xxx, xxx           xxx, xxx         xxx, xxx         xxx, xxx 
 xx.x               xx.x             xx.x             xx.xx  
 xx.x               xx.x             xx.x             xx.xx  
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients with non-missing data in the ITT Population for each treatment group. 
Compliant is defined as percentage compliance between 80.0% and 120.0%, inclusive.  
Program Name:                                  Date Generated:                                               Page x of y 
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Table 14.1.8.1 
Summary of Treatment Compliance 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
 P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
  (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
 Compliance Bottle Weight-1 Spray 
    
    <80% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    80% to 120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    >120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  
<Repeat for Bottle Weight-2 Spray, 3 sprays and 4 sprays> 
 
Compliance Bottle Weight-1-4 Spray 
 
    <80% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    80% to 120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    >120% 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients with non-missing data in the ITT Population for each treatment group. 
Compliant is defined as percentage compliance between 80.0% and 120.0%, inclusive.  
Program Name:                                  Date Generated:                                               Page x of y 
 
Repeat for the following displays: 
Table 14.1.8.2 Summary of Treatment Compliance Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients with non-missing data in the Safety Population for each treatment group. 
  Delete:  
    Footnote: The denominator for percentages is the number of patients with non-missing data in the ITT Population for each treatment group. 
 
 


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Table 14.1.9.1 
Summary of Treatment Exposure 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
 P-3074 + P       Vehicle + P        Vehicle + FNS     
  (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Duration (days) 
 
  n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 xx.x                xx.x               xx.x           
 xxx, xxx            xxx, xxx           xxx, xxx 
 xx.x                xx.x               xx.x           
 xx.x                xx.x               xx.x           
 
Duration of tablets exposure(days) 
 
  n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 xx.x                xx.x               xx.x           
 xxx, xxx            xxx, xxx           xxx, xxx 
 xx.x                xx.x               xx.x           
 xx.x                xx.x               xx.x           
 
Duration of spray exposure(days) 
 
  n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 xx.x                xx.x               xx.x           
 xxx, xxx            xxx, xxx           xxx, xxx 
 xx.x                xx.x               xx.x           
 xx.x                xx.x               xx.x           
____________________________________________________________________________________________________________________________________ 
Duration of overall exposure is calculated as (date of last dose/spray shot whichever comes later – date of first dose/spray shot whichever comes 
earlier) + 1 – off-drug (where both form of drugs were not used) days. 
Duration of table exposure is calculated as (date of last dose – date of first dose) + 1 – off-drug (tablets were not used) days. 
Duration of spray exposure is calculated as (date of last spray – date of first spray) + 1 – off-drug (spray were not used) days.  
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.1.9.2 Summary of Treatment Exposure Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients with non missing data in the Safety Population for each treatment group. 
Duration of overall exposure is calculated as (date of last dose/spray shot whichever comes later – date of first dose/spray shot whichever comes 
earlier) + 1 – off-drug (where both form of drugs were not used) days. 
  Delete:  
    Footnote: Duration of overall exposure is calculated as (date of last dose/spray shot whichever comes later – date of first dose/spray shot 
whichever comes earlier) + 1 – off-drug (where both form of drugs were not used) days. 
 


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Table 14.2.1.1 
Summary of Total Hair Count by Visit 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Baseline 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
<Visit> 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
  Change from Baseline 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
[Repeat for all scheduled visits] 
 
____________________________________________________________________________________________________________________________________ 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.2.2.1 Summary of Total Hair Count by Visit PP Population 
 
Table 14.2.3.1 Summary of Hair Width by Visit ITT Population 
 
Table 14.2.4.1 Summary of Hair Width by Visit PP Population 
 
Table 14.2.6.1 Summary of Patient Hair Growth/Loss Assessed by Blind Assessor by Visit ITT Population 
 
Table 14.2.7.1 Summary of Patient Hair Growth/Loss Assessed by Blind Assessor by Visit PP Population 
 


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Table 14.2.1.2 
Analysis of Change in Total Hair Count from Baseline after 12 and 24 Weeks of Treatment 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Number of patients 
xxx                 xxx                xxx             
Baseline Unadjusted Mean (SD) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 
12 Weeks Visit  
Unadjusted Mean (SD) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
Unadjusted Mean Change from Baseline(SE) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
Adjusted Mean Change from Baseline(SE)[a] 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 
Versus P-3074 + P                               
  LS Mean Difference (SE) [a] 
                    x.xx (x.xxx)            
  95% Confidence Interval [a] 
                    (x.xx , x.xx)             
  p-value [a] 
                    x.xxx           
 
____________________________________________________________________________________________________________________________________ 
[a] The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects 
and baseline hair count as a covariate with an unstructured covariance structure.  Change from Baseline by Visit is the reported result.  
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Table 14.2.1.2 
Analysis of Change in Total Hair Count from Baseline after 12 and 24 Weeks of Treatment 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
24 Weeks Visit  
Unadjusted Mean (SD) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
Unadjusted Mean Change from Baseline(SE) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
Adjusted Mean Change from Baseline(SE)[a] 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 
Versus P-3074 + P                               
  LS Mean Difference (SE) [a] 
                    x.xx (x.xxx)            
  95% Confidence Interval [a] 
                    (x.xx , x.xx)             
  p-value [a] 
                    x.xxx           
 
____________________________________________________________________________________________________________________________________ 
[a] The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects 
and baseline hair count as a covariate with an unstructured covariance structure.  Change from Baseline by Visit is the reported result.  
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.2.2.2 Analysis of Change in Total Hair Count from Baseline after 12 and 24 Weeks of Treatment PP Population 
 
Table 14.2.3.2 Analysis of Change in Hair Width from Baseline after 12 and 24 Weeks of Treatment ITT Population 
 
Table 14.2.4.2 Analysis of Change in Hair Width from Baseline after 12 and 24 Weeks of Treatment PP Population 
 
Table 14.2.5.2.1 
Analysis of Self-administered (MHGQ) Score - Bald Spot Getting Smaller as assessed by the Patient after 12 and 24 Weeks of 
Treatment ITT Population 
 
Table 14.2.5.2.2 
Analysis of Self-administered (MHGQ) Score -  Appearance of Your Hair as assessed by the Patient after 12 and 24 Weeks of 
Treatment ITT Population 
 
Table 14.2.5.2.3 
Analysis of Self-administered (MHGQ) Score - Growth of Hair as assessed by the Patient after 12 and 24 Weeks of Treatment 
ITT Population 
 
Table 14.2.5.2.4 
Analysis of Self-administered (MHGQ) Score - Effectiveness in Slowing Down Hair Loss as assessed by the Patient after 12 
and 24 Weeks of Treatment ITT Population 
 
Table 14.2.5.2.5 
Analysis of Self-administered (MHGQ) Score - The Hair Line at the Front of Your Head as assessed by the Patient after 12 
and 24 Weeks of Treatment ITT Population 
 
Table 14.2.5.2.6 
Analysis of Self-administered (MHGQ) Score - The Hair on Top of Your Head as assessed by the Patient after 12 and 24 Weeks 
of Treatment ITT Population 
 


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Table 14.2.5.4.1 
Analysis of Self-administered (MHGQ) Score - Bald Spot Getting Smaller as assessed by the Patient after 12 and 24 Weeks of 
Treatment PP Population 
 
Table 14.2.5.4.2 
Analysis of Self-administered (MHGQ) Score -  Appearance of Your Hair as assessed by the Patient after 12 and 24 Weeks of 
Treatment PP Population 
 
Table 14.2.5.4.3 
Analysis of Self-administered (MHGQ) Score - Growth of Hair as assessed by the Patient after 12 and 24 Weeks of Treatment 
PP Population 
 
Table 14.2.5.4.4 
Analysis of Self-administered (MHGQ) Score - Effectiveness in Slowing Down Hair Loss as assessed by the Patient after 12 
and 24 Weeks of Treatment PP Population 
 
Table 14.2.5.4.5 
Analysis of Self-administered (MHGQ) Score - The Hair Line at the Front of Your Head as assessed by the Patient after 12 
and 24 Weeks of Treatment PP Population 
 
Table 14.2.5.4.6 
Analysis of Self-administered (MHGQ) Score - The Hair on Top of Your Head as assessed by the Patient after 12 and 24 Weeks 
of Treatment PP Population 
 
Table 14.2.6.2 Analysis of Change in Patient Hair Growth/Loss Assessed by Blind Assessor ITT Population 
 
Table 14.2.7.2 Analysis of Change in Patient Hair Growth/Loss Assessed by Blind Assessor PP Population 
 
Table 14.2.8.2 Analysis of Change in Patient Hair Growth/Loss Assessed by Investigator ITT Population 
 
Table 14.2.9.2 Analysis of Change in Patient Hair Growth/Loss Assessed by Investigator PP Population 
 
Table 14.2.10.2.1 
Analysis of Change in Self-administered (IIEF-2) Erectile Function Score ITT Population 
 
Table 14.2.10.2.2 
Analysis of Change in Self-administered (IIEF-2) Orgasmic Function Score ITT Population 
 
Table 14.2.10.2.3 
Analysis of Change in Self-administered (IIEF-2) Sexual Desire Score ITT Population 
 
Table 14.2.10.2.4 
Analysis of Change in Self-administered (IIEF-2) Intercourse Satisfaction Score ITT Population 
 
Table 14.2.10.2.5 
Analysis of Change in Self-administered (IIEF-2) Overall Satisfaction Score ITT Population 
 
Table 14.2.10.4.1 
Analysis of Change in Self-administered (IIEF-2) Erectile Function Score PP Population 
 
Table 14.2.10.4.2 
Analysis of Change in Self-administered (IIEF-2) Orgasmic Function Score PP Population 
 
Table 14.2.10.4.3 
Analysis of Change in Self-administered (IIEF-2) Sexual Desire Score PP Population 
 
Table 14.2.10.4.4 
Analysis of Change in Self-administered (IIEF-2) Intercourse Satisfaction Score PP Population 
 
Table 14.2.10.4.5 
Analysis of Change in Self-administered (IIEF-2) Overall Satisfaction Score PP Population 
 
 


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Table 14.2.5.1 
Summary of Self-administered (MHGQ) Score by Visit  
ITT Population 
____________________________________________________________________________________________________________________________________ 
Bald Spot Getting Smaller as Assessed by 
the Patient 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
 
<Visit> 
Since the start of the study, I can see my 
bald spot getting smaller. 
Strongly agree (1) 
Agree (2) 
No Opinion either way (3) 
Disagree (4) 
Strongly disagree (5) 
 
Score 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
 
[Repeat for all scheduled visits] 
 
____________________________________________________________________________________________________________________________________ 
Note: A higher score indicates a worse outcome. 
Programming Notes: 
 
Include Bald Spot Getting Smaller as Assessed by the Patient, Appearance of My Hair as Assessed by the Patient, Growth of Hair as Assessed 
by the Patient , Effectiveness in Slowing Down Hair Loss as Assessed by the Patient , The Hair Line at the Front of Your Head as Assessed 
by the Patient, The Hair on Top of Your Head as Assessed by the Patient, and Overall as Assessed by the Patient. Start with a new page with 
a new a new question from the  questionnaire to be summarized. 
 
Please note, each question has it own number of options to be choosen and wording to be displayed. Please cross check with the original 
questionnaire with correct wording and number selection options. 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.2.5.3 Summary of Self-administered (MHGQ) Score by Visit  PP Population 
  Delete:  
    Note to Programmer: Please note, each question has it own number of options to be choosen and wording to be displayed. Please cross check 
with the original questionnaire with correct wording and number selection options. 
 
 


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Table 14.2.8.1 
Summary of Patient Hair Growth/Loss Assessed by Investigator by Visit 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
<Visit> 
Assessment of hair growth 
Greatly decreased (-3) 
Moderately decreased (-2) 
Slightly decreased (-1) 
No change (0) 
Slightly increased (1) 
Moderately increased (2) 
Greatly increased (3) 
 
Score 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
[Repeat for all scheduled visits] 
 
____________________________________________________________________________________________________________________________________ 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.2.9.1 Summary of Patient Hair Growth/Loss Assessed by Investigator by Visit PP Population 
 
 


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Table 14.2.10.1 
Summary of Self-administered (IIEF-2) Score by Visit 
ITT Population 
____________________________________________________________________________________________________________________________________ 
IIEF-2 Erectile Function Score 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Week 4 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
Week 8 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
 [Repeat for all IIEF-2 scheduled visits] 
 
____________________________________________________________________________________________________________________________________ 
Programming Notes: 
 
Include IIEF-2 Erectile Function Score, IIEF-2 Orgasmic Function Score, IIEF-2 Sexual Desire Score, IIEF-2 Intercourse Satisfaction score, 
and IIEF-2 Overall Satisfaction Score. Start with a new page with a new function domain from the IIEF-2 questionnaire to be summarized. 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.2.10.3 
Summary of Self-administered (IIEF-2) Score by Visit PP Population 
  Add:  
    Note to Programmer: Include IIEF-2 Erectile Function Score, IIEF-2 Orgasmic Function Score, IIEF-2 Sexual Desire Score, IIEF-2 Intercourse 
Satiscation score, and IIEF-2 Overall Satisfaction Score. Start with a new page with a new function domain from the IIEF-2 questionnaire to be 
summarized. 
  Delete:  
    Note to Programmer: Include IIEF-2 Erectile Function Score, IIEF-2 Orgasmic Function Score, IIEF-2 Sexual Desire Score, IIEF-2 Intercourse 
Satisfaction score, and IIEF-2 Overall Satisfaction Score. Start with a new page with a new function domain from the IIEF-2 questionnaire to be 
summarized. 
 
 


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Table 14.2.11.1 
Summary of Total Hair Count at Baseline to Week 12 (LOCF) 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Baseline 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
Week 12 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
  Change from Baseline 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
____________________________________________________________________________________________________________________________________ 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.2.12.1 
Summary of Total Hair Count at Baseline to Week 12 (LOCF) PP Population 
 
Table 14.2.13.1 
Summary of Total Hair Count at Baseline to Week 12 (BCA) ITT Population 
 
Table 14.2.14.1 
Summary of Total Hair Count at Baseline to Week 12 (BCA) PP Population 
 
Table 14.2.15.1 
Summary of Total Hair Count at Baseline to Week 12 (WCA) ITT Population 
 
Table 14.2.16.1 
Summary of Total Hair Count at Baseline to Week 12 (WCA) PP Population 
 
 


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Table 14.2.11.2 
Analysis of Change in Total Hair Count from Baseline after 12 Weeks of Treatment (LOCF) 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
Number of patients 
xxx                 xxx                xxx             
Baseline Unadjusted Mean (SD) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 
12 Weeks Visit  
Unadjusted Mean (SD) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
Unadjusted Mean Change from Baseline(SE) 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
Adjusted Mean Change from Baseline(SE)[a] 
 xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
 
Versus P-3074 + P                               
  LS Mean Difference (SE) [a] 
                    x.xx (x.xxx)            
  95% Confidence Interval [a] 
                    (x.xx , x.xx)             
  p-value [a] 
                    x.xxx           
 
____________________________________________________________________________________________________________________________________ 
[a] The analysis uses an ANCOVA model adjusted for treatment group, center, as fixed effects and baseline hair count as a covariate.  Change from 
Baseline by Visit is the reported result.  
Program Name:                                  Date Generated:                                               Page x of y 
 
Repeat for the following displays: 
Table 14.2.12.2 
Analysis of Change in Total Hair Count from Baseline after 12 Weeks of Treatment (LOCF) PP Population 
 
Table 14.2.13.2 
Analysis of Change in Total Hair Count from Baseline after 12 Weeks of Treatment (BCA) ITT Population 
 
Table 14.2.14.2 
Analysis of Change in Total Hair Count from Baseline after 12 Weeks of Treatment (BCA) PP Population 
 
Table 14.2.15.2 
Analysis of Change in Total Hair Count from Baseline after 12 Weeks of Treatment (WCA) ITT Population 
 
Table 14.2.16.2 
Analysis of Change in Total Hair Count from Baseline after 12 Weeks of Treatment (WCA) PP Population 
 
 


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Table 14.3.1.1 
Overall Frequency of Patients with Adverse Events 
Safety Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Patients with any TEAE 
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
  Patients with Mild TEAEs 
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Patients with Moderate TEAEs 
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Patients with Severe TEAEs [a] 
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Patients with any Study Drug Related  
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
TEAEs [a] 
 
 
Patients with any TEAE Leading to Discon- 
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
tinuation of Study  
 
Patients with any Study Drug Related  
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
TEAE Leading to Discontinuation of Study  
 
Patients with any Treatment Emergent  
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
Serious Adverse Events (TESAE)  
 
 
  Patients with any Study Drug Related  
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  TESAE [b] 
 
 
  Patients with any TESAE Leading to Death   
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
  Patients with any Study Drug Related 
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  TESAE Leading to Death 
 
  Patients with any TESAE Leading to  
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Discontinuation from Study 
 
  Patients with any Study Drug Related   
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  TESAE Leading to Discontinuation from Study 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients in the Safety Population 
[a] Cases with unknown intensity were assumed to be severe 
[b] Included are AEs considered relataed or possibly related to study drug and AEs with unknown or missing relationship to study drug 
 
Program Name:                                  Date Generated:                                               Page x of y 


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Table 14.3.1.2 
Summary of Treatment Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
Safety Population 
____________________________________________________________________________________________________________________________________ 
System Organ Class 
  Preferred Term 
 P-3074 + P                Vehicle + P              Vehicle + FNS            Overall Total      
 (N = xxx)                  (N = xxx)                 (N = xxx)               (N = xxx) 
 n (%)/e (%)                n (%)/e (%)               n (%)/e (%)              n (%)/e (%) 
____________________________________________________________________________________________________________________________________ 
 
Patients with any 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
 TEAE 
 
 
System Organ Class 1 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 1 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 2 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 3 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
.. etc. 
 
System Organ Class 2 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 1 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 2 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Preferred Term 3 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
.. etc. 
 
 
____________________________________________________________________________________________________________________________________ 
 
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
Note: This table contains counts of patients. If a patient experienced more than one episode of an adverse event, the patient is counted only 
once within a preferred term. If a patient experienced more than one adverse event within a system organ class, the patient is counted once 
for each preferred term and once for the system organ class.  
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.3.1.3 Summary of Treatment-Related Treatment Emergent Adverse Events by MedDRA System Organ Class and Preferred Term Safety Population 
 
Table 14.3.1.7 Summary of Treatment Emergent Adverse Events Causing Discontinuation from Study by MedDRA System Organ Class and Preferred Term 
Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients in the Safety Population 
  Delete:  
    Footnote:  
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
 


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Table 14.3.1.8 Summary of Treatment-Related Treatment Emergent Adverse Events Causing Discontinuation from Study by MedDRA System Organ Class and 
Preferred Term Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients in the Safety Population 
  Delete:  
    Footnote:  
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
 
Table 14.3.1.9 Summary of Treatment-Related Treatment Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term Safety 
Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients in the Safety Population 
  Delete:  
    Footnote:  
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
 
Table 14.3.1.10 
Summary of Adverse Events Leading to Death by MedDRA System Organ Class and Preferred Term Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients in the Safety Population 
  Delete:  
    Footnote:  
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
 
 


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Table 14.3.1.4 
Summary of Treatment Emergent Adverse Events by Relationship to Study Treatment by MedDRA System Organ Class and Preferred Term 
Safety Population 
____________________________________________________________________________________________________________________________________ 
System Organ Class 
  Preferred Term 
    Relationship to Study Drug 
 P-3074 + P                Vehicle + P              Vehicle + FNS            Overall Total   
 (N = xxx)                  (N = xxx)                 (N = xxx)               (N = xxx) 
 n (%)/e (%)                n (%)/e (%)               n (%)/e (%)              n (%)/e (%) 
____________________________________________________________________________________________________________________________________ 
 
Patients with Any TEAE 
 
  Overall 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Not Related 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Unlikely Related 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Possibly Related 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Related 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
 
System Organ Class 1 
 
  Overall 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Not Related 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Unlikely Related 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Possibly Related 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Related 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
 
  Preferred Term 1 
 
    Overall 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
    Not Related 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
    : 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
   
  Preferred Term 2 
 
    Overall 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
    Not Related 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
    : 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
   
  etc 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
 
 
____________________________________________________________________________________________________________________________________ 
 
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
Note: Patients with missing relationship to study drug are counted in the Overall category only. 
Note: This table contains counts of patients. If a patient experienced more than one episode of an adverse event, the patient is counted only 
once within a preferred term and for the episode that is most related to study drug. If a patient experienced more than one adverse event 
within a system organ class, the patient is counted once for each preferred term and once for the system organ class. 
 
Program Name:                                  Date Generated:                                               Page x of y 


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Table 14.3.1.5 
Summary of Treatment Emergent Adverse Events by Maximum Intensity System Organ Class and Preferred Term 
Safety Population 
____________________________________________________________________________________________________________________________________ 
System Organ Class 
  Preferred Term 
    Maximum Severity 
 P-3074 + P                Vehicle + P              Vehicle + FNS            Overall Total   
 (N = xxx)                  (N = xxx)                 (N = xxx)               (N = xxx) 
 n (%)/e (%)                n (%)/e (%)               n (%)/e (%)              n (%)/e (%) 
____________________________________________________________________________________________________________________________________ 
 
Patients with Any 
 
Maximum Intensity TEAE 
  Overall 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Mild 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Moderate 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
  Severe 
     xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)             xxx ( xx.x%)    
 
System Organ Class 1 
 
  Overall 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Mild 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Moderate 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
  Severe 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
 
  Preferred Term 1 
 
    Overall 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
    : 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
 
  Preferred Term 2 
 
    Overall 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
    : 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
    
  etc 
xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    xxx(xx.x%)/xxx(xx.x%)    
____________________________________________________________________________________________________________________________________ 
 
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
Note: Patients with missing maximum severity are considered as severe in this table. 
Note: This table contains counts of patients. If a patient experienced more than one episode of an adverse event, the patient is counted only 
once within a preferred term and for the episode with the maximum severity. If a patient experienced more than one adverse event within a 
system organ class, the patient is counted once for each preferred term and once for the system organ class. 
 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 


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Table 14.3.1.6 Summary of Treatment-Related Treatment Emergent Adverse Events by Maximum Intensity, System Organ Class and Preferred Term Safety 
Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients in the Safety Population 
    Footnote: Note: Patients with missing maximum severity are counted in the Overall category only. 
 
  Delete:  
    Footnote:  
n = number of patients in each category; The percentage is calculated as 100 x (n/N) 
e = number of episodes in each category; the percentage is calculate as 100 x (e/Total number of episodes) 
    Footnote: Note: Patients with missing maximum severity are considered as severe in this table. 
 
 
 


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Table 14.3.1.11 
Summary of Severity Score for Skin Irritation 
Safety Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
<Visit> 
Dermal Response  
No evidence of irritation 
Minimal erythema, barely perceptible 
Definite erythema, readily visible; minimal oedema or minimal 
 papular response 
Erythema and papules 
Definite oedema 
Erythema, oedema and papules 
Vescicular eruption 
Strong reaction spreading beyond test site 
 
Other Effects 
No other effects 
Slightly glazed appearance 
Marked glazing 
Glazing with peeling and cracking 
Glazing with fissures 
Film of dried serour exudate covering all or part of the patch  
 site 
Small petechial erosions or scabs 
 
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
xxx ( xx.x%)        xxx ( xx.x%)     xxx ( xx.x%)    
 
[Repeat for all scheduled visits] 
 
____________________________________________________________________________________________________________________________________ 
The denominator for percentages is the number of patients with non-missing data in the Safety Population for each treatment group.  
Program Name:                                  Date Generated:                                               Page x of y 


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Table 14.3.1.12 
Incidence Rate of Severity Score for Skin Irritation 
Safety Population 
____________________________________________________________________________________________________________________________________ 
 
       P-3074 + P                Vehicle + P               Vehicle + FNS     
        (N = xxx)                 (N = xxx)                  (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Incidence Rate of Skin Irritation 
Dermal Response 
    Treatment Period 
    Overall Study Period 
 
Other Effects 
    Treatment Period 
    Overall Study Period 
 
      Total                        Total                        Total     
N      Time     Incidenc     N      Time     Incidence    N      Time     Incidence      
Events (Years)  Rate         Events (Years)  Rate         Events (Years)  Rate  
xxx     xxx     xxxx         xxx     xxx     xxxx         xxx     xxx     xxxx   
xxx     xxx     xxxx         xxx     xxx     xxxx         xxx     xxx     xxxx   
xxx     xxx     xxxx         xxx     xxx     xxxx         xxx     xxx     xxxx   
xxx     xxx     xxxx         xxx     xxx     xxxx         xxx     xxx     xxxx   
 
 
____________________________________________________________________________________________________________________________________ 
Event incidence rate is calculated as the number of events interest devided by total personal time in years.  
Program Name:                                  Date Generated:                                               Page x of y 


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Table Listing 14.3.2 
Serious Treatment Emergent Adverse Events 
Safety Population 
 
Treatment group: Treatment 1 
 
 
 
Site 
 
 
Patient/
Age 
AE Line No./ 
System Organ Class/ 
Preferred Term/ 
Verbatim [a] 
Start Date (day) 
Stop Date (day)[b] 
 / Duration (days) 
 
Intensity/ 
Frequency 
Relationship 
to Study Drug/ 
Action 
Taken[c] 
 
Outcome/ 
Discontinue? 
 
Medically 
Important 
but not 
SAE 
 
SAE 
Type 
[d] 
 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
1/ 
xxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
DDMMMYYYY (xx) 
 DDMMMYYYY (xx) 
 /xx 
 
Mild/ 
Single 
Event 
Not Related/ 
xxx 
Resolved/ 
No 
No 
2 
 
 
 
2/ 
xxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
 
DDMMMYYYY (xx)/ 
DDMMMYYYY (xx)/xx 
Moderate/ 
Single 
Event 
Unlikely/ 
xxx 
Death/ 
Yes 
No 
3, 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
1/ 
xxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
DDMMMYYYY (xx)/ 
Ongoing 
Severe/ 
Single 
Event 
Possibly/ 
xxx 
Ongoing/ 
No 
No 
3 
 
 
 
 
 
 
 
 
 
 
 
 
[a] Coded using MedDRA Dictionary (Version 19.0) 
[b] Relative to the day of first dose of study treatment group 
[c] Action Taken: Inc=Dose increased; No Chg=Dose not changed; Red=Dose reduced; Int=Drug interrupted; Withd=Drug withdrawn; NA=Not 
applicable; Un=Unknown; Oth=Other. 
[d] SAE Type: 1=Death; 2=Life Threatening; 3=Initl or Prolonged Hospitalization; 4=Persistent or Significant Disability or Incapacity; 
5=Congenital Anomaly or Birth Defect.  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient, start date and SOC. 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Table 14.3.4.1 
Shift Table of Hematology Test Results 
Safety Population 
____________________________________________________________________________________________________________________________________ 
Parameter (unit) 
Time point 
 P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
  (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Hematocrit (unit) 
 
Week 8 
xxx                xxx              xxx              xxx             
 
Baseline Low to Low 
  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
Baseline Low to Normal    
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
Baseline Low to High    
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Baseline Normal to Low  
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
Baseline Normal to Normal 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)      
Baseline Normal to High 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)      
 
Baseline High to Low   
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
Baseline High to Normal 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
Baseline High to High   
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
<Repeat for Week 24> 
<Continue for Early Termination Visit> 
 
 
____________________________________________________________________________________________________________________________________ 
Note: This table only presents results for patients with non-missing data at baseline and the time point of interest. 
Note: Low = below lower limit of normal range, Normal = within normal limits, High = above upper limit of normal range. 
Programming Notes: 
 
Include hemoglobin,  Hematology, Eosinophils, Eosinophils(%), Basophils, Basophils(%), Lymphocytes, Lymphocytes(%), Neutrophils, 
Neutrophils(%), Monocytes, Monocytes(%), Erythrocytes, Thrombocytes, Mean Corpuscular Volume (MCV), Mean Corpuscular hemoglobin (MCH), Mean 
Corpuscular Hemoglobin Concentration(MCHC) in the same table. Start with a new page with an analyte to be summarized. 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.3.4.2 Shift Table of Serum Chemistry Test Results Safety Population 
  Add:  
    Note to Programmer: Include Alanie aminotranferase (ALT),  Aspartate aminotranferase (AST), Total Bilirubin, Total Cholesterol, Triglycerides,  
Gamma-Glutamyltransferase (GGT), Alkaline phosphatase, Albumin, Total protein, Glucose, Creatinine,  Globulin, Calcium,  Potassium, Chloride, 
Testosterone, Sodium,  Inorganic Phosphorus, Uric acid, Urea  in the same table. Start with a new page with an analyte to be summarized. 
  Delete:  
    Note to Programmer: Include hemoglobin,  Hematology, Eosinophils, Eosinophils(%), Basophils, Basophils(%), Lymphocytes, Lymphocytes(%), 
Neutrophils, Neutrophils(%), Monocytes, Monocytes(%), Erythrocytes, Thrombocytes, Mean Corpuscular Volume (MCV), Mean Corpuscular hemoglobin 
(MCH), Mean Corpuscular Hemoglobin Concentration(MCHC) in the same table. Start with a new page with an analyte to be summarized. 
 


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Table 14.3.4.3.2.1 
Shift Table of Urinalysis Test Results ITT Population 
  Add:  
    Note to Programmer: Include Specific Weight, pH, Leukocytes, and Erythrocytes Start with a new page with an analyte to be summarized. 
  Delete:  
    Note to Programmer: Include hemoglobin,  Hematology, Eosinophils, Eosinophils(%), Basophils, Basophils(%), Lymphocytes, Lymphocytes(%), 
Neutrophils, Neutrophils(%), Monocytes, Monocytes(%), Erythrocytes, Thrombocytes, Mean Corpuscular Volume (MCV), Mean Corpuscular hemoglobin 
(MCH), Mean Corpuscular Hemoglobin Concentration(MCHC) in the same table. Start with a new page with an analyte to be summarized. 
    Footnote: Note: This table only presents results for patients with non-missing data at baseline and the time point of interest. 
    Footnote: Note: Low = below lower limit of normal range, Normal = within normal limits, High = above upper limit of normal range. 
 
Table 14.3.4.3.2.2 
Shift Table of Urinalysis Test Results Safety Population 
  Add:  
    Note to Programmer: Include Specific Weight, pH, Leukocytes, and Erythrocytes Start with a new page with an analyte to be summarized. 
  Delete:  
    Note to Programmer: Include hemoglobin,  Hematology, Eosinophils, Eosinophils(%), Basophils, Basophils(%), Lymphocytes, Lymphocytes(%), 
Neutrophils, Neutrophils(%), Monocytes, Monocytes(%), Erythrocytes, Thrombocytes, Mean Corpuscular Volume (MCV), Mean Corpuscular hemoglobin 
(MCH), Mean Corpuscular Hemoglobin Concentration(MCHC) in the same table. Start with a new page with an analyte to be summarized. 
    Footnote: Note: This table only presents results for patients with non-missing data at baseline and the time point of interest. 
    Footnote: Note: Low = below lower limit of normal range, Normal = within normal limits, High = above upper limit of normal range. 
 
 


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Table 14.3.4.3.1.1 
Shift Table of Urinalysis Test Results 
ITT Population 
____________________________________________________________________________________________________________________________________ 
Glucose 
       P-3074 + P                 Vehicle + P             Vehicle + FNS              Overall Total 
       (N = xxx)                  (N = xxx)                (N = xxx)                 (N = xxx) 
________Baseline_______   ________Baseline_______   ________Baseline_______   ________Baseline_______ 
 N  T 1+ 2+ 3+ 4+ Tot      N  T  1+ 2+ 3+ 4+ Tot      N  T  1+ 2+ 3+ 4+ Tot     N  T  1+ 2+ 3+ 4+ Tot 
____________________________________________________________________________________________________________________________________ 
 
Week 8 
  Normal (N) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Trace (T) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  1+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  2+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  3+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  4+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Total (Tot) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
 
Week 24 
  Normal (N) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Trace (T) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  1+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  2+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  3+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  4+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Total (Tot) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
 
<Continue for Early Termination Visit> 
 
____________________________________________________________________________________________________________________________________ 
Programming Notes: 
 
Include Proteins, Glucose, Urobilinogen, and Ketones. Start with a new page with an analyte to be summarized. 
 
For glucose, the readings are “Normal (N)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”. 
For proteins and ketones, the readings are “Negative (-)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”.  
For urobilinogen, the readings are “Normal (N)”, “1+”, “2+”, “3+”, “4+”.    
Programmers need to update the reading ranges accordingly. If there is only 5 options instead of 6 move up if display vertically and move left if 
displays horizontally. 
 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Table 14.3.4.3.1.1 
Shift Table of Urinalysis Test Results 
ITT Population 
____________________________________________________________________________________________________________________________________ 
Protein 
       P-3074 + P                 Vehicle + P             Vehicle + FNS              Overall Total 
       (N = xxx)                  (N = xxx)                (N = xxx)                 (N = xxx) 
________Baseline_______   ________Baseline_______   ________Baseline_______   ________Baseline_______ 
 N  T 1+ 2+ 3+ 4+ Tot      N  T  1+ 2+ 3+ 4+ Tot      N  T  1+ 2+ 3+ 4+ Tot     N  T  1+ 2+ 3+ 4+ Tot 
____________________________________________________________________________________________________________________________________ 
 
Week 8 
  Negative (-) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Trace (T) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  1+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  2+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  3+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  4+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Total (Tot) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
 
Week 24 
  Negative (-) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Trace (T) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  1+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  2+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  3+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  4+ 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
  Total (Tot) 
 xx xx xx xx xx xx xx       xx xx xx xx xx xx xx       xx xx xx xx xx xx xx      xx xx xx xx xx xx xx 
 
<Continue for Early Termination Visit> 
 
____________________________________________________________________________________________________________________________________ 
Programming Notes: 
 
Include Proteins, Glucose, Urobilinogen, and Ketones. Start with a new page with an analyte to be summarized. 
 
For glucose, the readings are “Normal (N)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”. 
For proteins and ketones, the readings are “Negative (-)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”.  
For urobilinogen, the readings are “Normal (N)”, “1+”, “2+”, “3+”, “4+”.    
Programmers need to update the reading ranges accordingly. If there is only 5 options instead of 6 move up if display vertically and move left if 
displays horizontally. 
 
Program Name:                                  Date Generated:                                               Page x of y 
 


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Table 14.3.4.3.1.1 
Shift Table of Urinalysis Test Results 
ITT Population 
____________________________________________________________________________________________________________________________________ 
Protein 
     P-3074 + P             Vehicle + P         Vehicle + FNS          Overall Total 
     (N = xxx)              (N = xxx)            (N = xxx)             (N = xxx) 
______Baseline_____   ______Baseline_____   ______Baseline_____   ______Baseline_____ 
 N  1+ 2+ 3+ 4+ Tot   N  1+ 2+ 3+ 4+ Tot    N  1+ 2+ 3+ 4+ Tot    N  1+ 2+ 3+ 4+ Tot 
____________________________________________________________________________________________________________________________________ 
 
Week 8 
  Normal (N) 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  1+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  2+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  3+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  4+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  Total (Tot) 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
 
Week 24 
  Normal (N) 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  1+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  2+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  3+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  4+ 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
  Total (Tot) 
 xx  xx xx xx xx xx    xx xx xx xx xx xx     xx xx xx xx xx xx     xx xx xx xx xx xx  
 
<Continue for Early Termination Visit> 
 
____________________________________________________________________________________________________________________________________ 
Programming Notes: 
 
Include Proteins, Glucose, Urobilinogen, and Ketones. Start with a new page with an analyte to be summarized. 
 
For glucose, the readings are “Normal (N)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”. 
For proteins and ketones, the readings are “Negative (-)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”.  
For urobilinogen, the readings are “Normal (N)”, “1+”, “2+”, “3+”, “4+”.    
Programmers need to update the reading ranges accordingly. If there is only 5 options instead of 6 move up if display vertically and move left if 
displays horizontally. 
 
Program Name:                                  Date Generated:                                               Page x of y 
 
 
Repeat for the following displays: 


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Table 14.3.4.3.1.2 
Shift Table of Urinalysis Test Results Safety Population 
  Delete:  
    Note to Programmer: For glucose, the readings are “Normal (N)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”. 
For proteins and ketones, the readings are “Negative (-)”, “Trace (T)”, “1+”, “2+”, “3+”, “4+”.  
For urobilinogen, the readings are “Normal (N)”, “1+”, “2+”, “3+”, “4+”.    
Programmers need to update the reading ranges accordingly. If there is only 5 options instead of 6 move up if display vertically and move left if 
displays horizontally. 
 
 
 


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Table 14.3.4.3.3.1 
Shift Table of Urinalysis Test Results 
ITT Population 
____________________________________________________________________________________________________________________________________ 
Nitrites 
    P-3074 + P           Vehicle + P       Vehicle + FNS       Overall Total 
     (N = xxx)            (N = xxx)          (N = xxx)          (N = xxx) 
 ____Baseline____     ____Baseline____   ____Baseline____   ____Baseline____ 
  Pos   Neg   Tot      Pos   Neg   Tot    Pos   Neg   Tot    Pos   Neg   Tot 
____________________________________________________________________________________________________________________________________ 
Week 8 
  Positive (Pos) 
  xxx   xxx   xxx      xxx   xxx   xxx    xxx   xxx   xxx    xxx   xxx   xxx  
  Negative (Neg) 
  xxx   xxx   xxx      xxx   xxx   xxx    xxx   xxx   xxx    xxx   xxx   xxx  
  Total (Tot) 
  xxx   xxx   xxx      xxx   xxx   xxx    xxx   xxx   xxx    xxx   xxx   xxx  
 
Week 24 
  Positive (Pos) 
  xxx   xxx   xxx      xxx   xxx   xxx    xxx   xxx   xxx    xxx   xxx   xxx  
  Negative (Neg) 
  xxx   xxx   xxx      xxx   xxx   xxx    xxx   xxx   xxx    xxx   xxx   xxx  
  Total (Tot) 
  xxx   xxx   xxx      xxx   xxx   xxx    xxx   xxx   xxx    xxx   xxx   xxx  
 
<Continue for Early Termination Visit> 
 
 
____________________________________________________________________________________________________________________________________ 
Programming Notes: 
 
Include Specific Nitrites and Bilirubin. Start with a new page with an analyte to be summarized. 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.3.4.3.3.2 
Shift Table of Urinalysis Test Results Safety Population 
 
 


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Table 14.3.5.1 
Summary of Vital Signs  
ITT Population 
____________________________________________________________________________________________________________________________________ 
Weight (unit) 
P-3074 + P       Vehicle + P        Vehicle + FNS     
 (N = xxx)        (N = xxx)          (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Baseline 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
<Visit> 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
  Change from Baseline 
n 
Mean (SD) 
Median 
Q1, Q3 
Min 
Max 
xxx                 xxx                xxx             
xx.x ( xx.xx)       xx.x ( xx.xx)      xx.xx ( xx.xx)       
xx.x                xx.x               xx.x           
xxx, xxx            xxx, xxx           xxx, xxx 
xx.x                xx.x               xx.x           
xx.x                xx.x               xx.x           
 
[Repeat for all scheduled visits] 
 
____________________________________________________________________________________________________________________________________ 
Programming Notes: 
 
Include Weight, Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, and Temperature. Start with a new page with an analyte to be 
summarized. 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.3.5.2 Summary of Vital Signs  Safety Population 
 
 


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Table 14.3.6.1 
Summary of Physical Exam 
ITT Population 
____________________________________________________________________________________________________________________________________ 
 
P-3074 + P       Vehicle + P      Vehicle + FNS      Overall Total      
 (N = xxx)        (N = xxx)          (N = xxx)         (N = xxx) 
____________________________________________________________________________________________________________________________________ 
 
Screening 
xxx                xxx              xxx              xxx             
Any Abnormality?[a] 
 
  Normal 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Abnormal not clinically significant 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Abnormal clinically significant 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Not done 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
 
Abnormalities by Body System  
  Body System 1 
 
    Normal 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    Abnormal not clinically significant 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    Abnormal clinically significant 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    Not done 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Body System 2 
 
    Normal 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    Abnormal not clinically significant 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    Abnormal clinically significant 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
    Not done 
xxx ( xx.x%)       xxx ( xx.x%)     xxx ( xx.x%)     xxx ( xx.x%)    
  Body System 3 
 
  : 
 
<Repeat for all visits> 
 
____________________________________________________________________________________________________________________________________ 
[a] Count are based on the worst severity documented on the CRF at the visit. 
The denominator for percentages is the number of patients with non-missing data in theITT Population for each treatment group.  
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Table 14.3.6.2 Summary of Physical Exam Safety Population 
  Add:  
    Footnote: The denominator for percentages is the number of patients with non-missing data in theSafety Population for each treatment group.  
  Delete:  
    Footnote: The denominator for percentages is the number of patients with non-missing data in theITT Population for each treatment group.  
 
 


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Listing 16.2.1.1 
Patients Screened 
All Screened Patients 
 
Treatment group: Treatment 1 
 
Site 
 
Patient/
Age 
 
Date of Informed 
Consent 
Date of Screen 
Failure 
Reason(s) for Screen 
Failure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
DDMMMYYYY 
DDMMMYYYY 
Reason 1; Reason 2 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
DDMMMYYYY 
DDMMMYYYY 
Reason 1 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
DDMMMYYYY 
DDMMMYYYY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.1.2 
Patients Disposition 
All Randomized Population 
Treatment group: Treatment 1 
 
Site 
 
Patient 
 
Age 
(year) 
Completed 
Study 
 
Primary Reason for 
Withdrawal 
Date of 1st Dose of 
Study Treatment group/ 
Date of 1st Spray of 
Study Treatment group 
Date of 
Withdrawal 
(Day)[a] 
 
 
Date of Last Dose of 
Study Treatment group 
(Day)[a]/ 
Date of Last Spray of 
Study Treatment group 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx 
xx 
No 
 
Reason 1 
DDMMMYYYY/ 
DDMMMYYYY 
 
DDMMMYYYY (xx) 
 
 
DDMMMYYYY (xx)/ 
DDMMMYYYY (xx) 
 
xx 
xxx 
xx 
No 
 
Reason 2 
DDMMMYYYY/ 
DDMMMYYYY 
 
DDMMMYYYY (xx) 
 
 
DDMMMYYYY (xx)/ 
DDMMMYYYY (xx) 
 
xx 
xxx 
xx 
Yes 
 
 
DDMMMYYYY/ 
DDMMMYYYY 
 
 
 
DDMMMYYYY (xx)/ 
DDMMMYYYY (xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a] Relative to date of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.1.3 
Patients Disposition 
All Randomized Population 
 
Treatment group Group: P-3074 + P 
 
Site 
 
Patient/
Age 
 
 
 
Visit 
Date Visit (Day) 
[a] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
 
Screening 
DDMMMYYYY (xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
DDMMMYYYY (xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Week 4 
DDMMMYYYY (xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Week 8 
DDMMMYYYY (xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Week 12 
DDMMMYYYY (xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a] Relative to date of first dose of study treatment group  
Programming notes: Repeat for all treatment group groups. Sort by treatment group group, site and patient 
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 
 
 


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Listing 16.2.1.4 
Patients Treatment Allocation 
All Randomized Population 
 
 
Site 
 
Patient/Age 
 
Randomized 
Treatment Group 
 
 
Date of 
Randomization  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
Treatment x 
 
 
DDMMMYYYY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Programming Notes: 
 
Repeat for all treatment groups. Sort by site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.1.5 
Protocol Violations 
All Randomized Population 
 
Treatment group: Treatment 1 
Site 
Patient/Age  
Any Violations? 
Date 
Violation Category 
 
 
Details of Violation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
Yes 
DDMMMYYYY 
xxxxxxxxxxxxxxxx 
 
 
xxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Violations were identified and categorized prior to unblinding.  Patients may have more than one violation leading to exclusion 
from All Randomized Population  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.2.1 
Inclusion Criteria 
All Screened Patients 
 
Treatment group: Treatment 1 
Site 
Patient/Age Protocol 
Version 
I1 
I2 
I3 
I4 
I5 
I6 
I7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
1 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
 
 
 
 
 
 
xx 
xxx/xx 
1 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Refer to Preface A for full descriptions of the Inclusion and Exclusion Criteria.  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.2.2 
Exclusion Criteria 
All Screened Patients 
 
Treatment group: Treatment 1 
Site 
Patient 
/Age 
E1 
E2 
E3 
E4 
E5 
E6 
E7 
E8 
E9 
E10 
E11 
E12 
E13 E14 E15 E16 
E17 
E18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
Yes 
Yes 
NA 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
No 
Yes 
NA 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Refer to Preface A for full descriptions of the Inclusion and Exclusion Criteria. 
[a]  Relative to the day of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.3 
Study Population 
All Screened Patients 
Treatment group: Treatment 1 
Site 
Patient/
Age 
 
 
 
All Screened 
Patient 
 
All 
Randomized 
Population 
 
Safety 
Population 
 
ITT 
Population 
 
Per Protocol 
Population 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
 
 
Yes 
 
Yes 
 
Yes 
 
Yes 
 
Yes 
 
xx 
xxx/xx 
 
 
 
Yes 
 
Yes 
 
Yes 
 
No 
 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 
CCI


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Listing 16.2.4.1 
Demographics 
All Randomized Population 
 
Treatment group: Treatment 1 
Site 
Patient/
Age 
 
Year of Birth 
 
 
Race 
Ethnicity 
Current Tobacco 
Use/ 
Smoke>=10 
cigerretts per day 
Current Alocohol 
Use 
Drink>5 Cups of 
coffee/tea per 
day 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
YYYY 
 
 
Race1 
Ethnicity1 
Never/No 
None 
Yes 
xx 
xxx/xx 
 
YYYY 
 
 
Race2 
Ethnicity2 
Current/No 
<=2 drinks per day 
Yes 
xx 
xxx/xx 
 
YYYY 
 
 
Other: xxxx 
Ethnicity3 
Former/Yes 
> 2 drinks per day 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.4.2 
Medical History 
All Randomized Population 
 
Treatment group: Treatment 1 
 
 
Site 
 
Patient/
Age 
 
 
Vertex Pattern 
 
System  Organ Code (SOC)/  
Preferred Term (PT)[a]/ 
Verbatim/ 
MMH Line No. 
 
 
 
 
 
Start Date/ 
Stop Date[b] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
Type III 
 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
1 
 
 
 
 
 
DDMMMYYYY/ 
DDMMMYYYY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/x 
 
Type IV 
 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
1 
 
 
 
 
 
DDMMMYYY/ 
Ongoing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
Other: xxxxx 
 
None 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a] MedDRA Dictionary (Version 19.0) was used for coding  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient, SOC and preferred term. 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.4.3 
Prior and Concomitant Medication 
All Randomized Population 
 
Treatment group: Treatment 1 
 
 
 
Site 
 
 
Patient 
/Age 
 
 
Therapeutic Class 
 Chemical Subgroup 
  Generic Term [a] 
 
 
Dose/Unit/ 
Frequency/ 
Route 
 
 
 
Indication 
CM Number 
 
 
Start Date (day) 
 Stop Date (day)[b] 
 / Duration (days) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
xxxxxxxxxx 
 xxxxxxxxxxxxxx 
  (xxxxxxxxxxxx) 
 
xx/units/ 
xx/ 
xx 
 
xxxxxxxxxx 
xx, xx /1 
 
DDMMMYYYY (xx) 
 DDMMMYYYY (xx) 
 /xx 
 
 
 
 
 
 
 
 
 
 
xxxxxxxxxx 
 xxxxxxxxxxxxxx 
  (xxxxxxxxxxxx) 
 
xx/units/ 
xx/ 
xx 
 
xxxxxxxxxx 
xx, xx /2 
 
DDMMMYYYY (xx)/ 
 DDMMMYYYY (xx)/xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
xxxxxxxxxx 
 xxxxxxxxxxxxxx 
  (xxxxxxxxxxxx) 
 
xx/units/ 
xx/ 
xx 
 
xxxxxxxxxx 
xx, xx /1 
 
DDMMMYYYY (xx)/ 
Ongoing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
None 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a] WHO Drug Dictionary (Version MAR16B2E) was used for coding 
[b] Relative to date of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient, start date and drug class. 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.5.1 
Study Drug Administration (Tablet) 
All Randomized Population 
 
Treatment group Group: P-3074 + P 
 
 
Site 
 
Patient/ 
Age 
 
Start Date 
Time of 
Treatment 
 
Last Date Time 
of Treatment 
 
 
Start Date of 
Interruption 
(day) [a] 
 
End Date of 
Interruption (day) 
[a] 
 
Actual 
Treatment 
Received 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
DDMMMYYYY 
HH:MM 
DDMMMYYYY HH:MM 
DDMMMYYYY (xx) 
 
DDMMMYYYY (xx) 
 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a]  Relative to the day of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 


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Listing 16.2.5.2 
Study Drug Administration (Spray) 
All Randomized Population 
 
Treatment group Group: P-3074 + P 
 
 
Site 
 
Patient/ 
Age 
 
Start Date 
Time of 
Treatment 
 
Last Date Time 
of Treatment 
 
 
Start Date of 
Interruption 
(day) [a] 
 
End Date of 
Interruption (day) 
[a] 
 
Actual 
Treatment 
Received 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
DDMMMYYYY 
HH:MM 
DDMMMYYYY HH:MM 
DDMMMYYYY (xx) 
 
DDMMMYYYY (xx) 
 
xxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a]  Relative to the day of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
Program Name:                                  Date Generated:                                               Page x of y 


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Listing 16.2.5.3 
Study Treatment Compliance/Exposure 
All Randomized Population 
 
Treatment group: Treatment 1 
 
 
 
Compliance Based on Diary 
 
Compliance Based Accountability 
 
 
 
 
 
 
 
 
Site 
Patient/ 
Age 
 
Tablets (%) 
Spray Shot (%) 
 
Tablets (%) 
Spray Shot (%) 
    Duration of 
    Exposure (days) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
xx.x% 
xx.x% 
 
 xx.x% 
xx.x% 
    xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient and visit. 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.6.1 
Hair Assessment Results 
All Randomized Population 
 
Treatment group: Treatment 1 
Site 
Patient/Age 
Visit 
Date (day) 
[a] 
 
 
Hair Count 
 
Hair Width 
(unit) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
 
 
 
 
10 
 
10.36    12.23   13.15   8.33   6.45   9.32   6.88    
 
 
 
 
 
 
 
 
7.55     8.65   8.99 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a]  Relative to the day of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site and patient 
 
Please include all measured hair width in this listing. 
Program Name:                                  Date Generated:                                               Page x of y 


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Listing 16.2.6.2 
MHGQ Questionnaire 
All Randomized Population 
 
Treatment group: Treatment 1 
Site 
Patient/
Age 
Visit 
Collection 
Data(day) [a] 
Question 
Patient’s Response/Score 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
Week 12 
DDMMMYYYY(xx) 
Bald spot getting smaller? 
Agree/2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appreance of my hair is: 
A littie better/3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Growth of my hair 
Slightly increased/3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Effctive of the treatment 
Somehow effective/2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hairline at the frond  
I am very satisfied/1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hair on top  
I am satisfied/2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Overall 
I am satisfied/2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a]  Relative to the day of first dose of study treatment group  
 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.6.3 
Blind Assessor Assessment of Patient Hair Growth/Loss Change from Baseline 
All Randomized Population 
 
Treatment group: Treatment 1 
Site 
Patient/
Age 
Visit 
Assessment 
Data(day) [a] 
Assessment of Hair Growth 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
Week 12 
DDMMMYYYY(xx) 
Greatly Increased 
 
 
 
 
 
 
 
 
 
 
 
 
 
Week 24 
DDMMMYYYY(xx) 
Greatly Increased 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a]  Relative to the day of first dose of study treatment group  
 
Program Name:                                  Date Generated:                                               Page x of y 
 
 
Repeat for the following displays: 
Listing 16.2.6.4 
Investigator's Assessment of Patient Hair Growth/Loss Change from Baseline All Randomized Population 
  Delete:  
    Footnote: [a]  Relative to the day of first dose of study treatment group 
 
 


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Listing 16.2.7.1 
Adverse Events 
Safety Population 
 
Treatment group: Treatment 1 
 
 
 
Site 
 
Patient/
Age 
AE Line No./ 
System Organ Class/ 
Preferred Term/ 
Verbatim [a] 
TEAE or PTAE/ 
Start Date (day) 
Stop Date (day)[b] 
 / Duration (days) 
 
Intensity/ 
Frequency 
Relationship 
to Study Drug/ 
Action 
Taken[c] 
 
Outcome/ 
Discontinue? 
 
Medically 
Important 
but not 
SAE 
 
SAE[d] 
 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
1/ 
xxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
TEAE/ 
DDMMMYYYY (xx) 
 DDMMMYYYY (xx) 
 /xx 
 
Mild/ 
Single 
Event 
Not Related/ 
xxx 
Resolved/ 
No 
No 
No 
 
 
 
2/ 
xxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
 
TEAE/ 
DDMMMYYYY (xx)/ 
DDMMMYYYY (xx)/xx 
Moderate/ 
Single 
Event 
Unlikely/ 
xxx 
Death/ 
Yes 
No 
Yes:1 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
1/ 
xxxxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxxxx/ 
xxxxxxxxxxxxxxx/ 
PTAE/ 
DDMMMYYYY (xx)/ 
Ongoing 
Severe/ 
Single 
Event 
Not Related/ 
xxx 
Ongoing/ 
No 
No 
Yes:3 
 
 
 
 
 
 
 
 
 
 
 
 
[a] Coded using MedDRA Dictionary (Version 19.0) 
[b] Relative to the day of first dose of study treatment group 
[c] Action Taken: Inc=Dose increased; No Chg=Dose not changed; Red=Dose reduced; Int=Drug interrupted; Withd=Drug withdrawn; NA=Not 
applicable; Un=Unknown; Oth=Other 
[d] SAE Type: 1=Death; 2=Life Threatening; 3=Initl or Prolonged Hospitalization; 4=Persistent or Significant Disability or Incapacity; 
5=Congenital Anomaly or Birth Defect  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient, start date and SOC. 
Program Name:                                  Date Generated:                                               Page x of y 
 
 
Repeat for the following displays: 
Listing 16.2.7.2 
Treatment Emergent Adverse Events Leading to Discontinuation of Treatment Safety Population 
 
Listing 16.2.7.3 
Death Safety Population 
 
 


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Listing 16.2.7.4 
Severity Score for Skin Irritation 
Safety Population 
 
Treatment group: Treatment 1 
Site 
Patient/
Age 
Visit 
Collection 
Data(day) [a] 
Dermal Response 
Other Effects 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
Week 4 
DDMMMYYYY(xx) 
No evidence of irritation 
No other effetcs 
 
 
 
 
 
 
 
 
 
 
 
 
Week 8 
DDMMMYYYY(xx) 
Erythema and papules 
Marked glazing 
 
 
 
 
 
 
 
 
 
 
 
 
Week 12 
DDMMMYYYY(xx) 
Erythema, oedema and papules 
Marked glazing 
 
 
 
 
 
 
 
 
 
 
 
 
Week 24 
DDMMMYYYY(xx) 
Vescicular eruption 
Slight glazed appearance 
 
 
 
 
 
 
 
 
 
 
 
 
Week 28 
DDMMMYYYY(xx) 
Strong reaction spreading beyond 
test site 
No other effetcs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
Week 4 
DDMMMYYYY(xx) 
No evidence of irritation 
No other effetcs 
 
 
 
 
 
 
 
 
 
 
 
 
 
: 
: 
: 
 
 
 
 
 
 
 
 
 
 
 
 
 
: 
: 
: 
 
 
 
 
 
 
 
 
 
 
 
 
 
: 
: 
: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.8.1 
Preface to Laboratory Findings 
Safety Population 
 
 
 
    Laboratory Test 
Sex 
Age 
Reference Ranges 
Unit 
     
 
 
     
 
 
 
 
     
 
 
    Hematology 
 
 
xxxxxxx - xxxxxxx 
 
     
 
 
     
 
 
 
 
     
 
 
       Hematocrit 
 
 
 
(unit) 
     
 
 
       Hemoglobin 
 
 
 
(unit) 
     
 
 
       . . . 
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
    Serum Chemistry 
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
       ALT 
 
 
 
(unit) 
     
 
 
       AST 
 
 
 
(unit) 
     
 
 
       . . . 
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
     
 
 
 
 
     
 
 
 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.8.2 
Laboratory Findings - Hematology 
Safety Population 
 
Treatment group: Treatment 1 
 
Site 
 
Patient/ 
Age 
 
 
Nominal 
Visit 
 
Laboratory 
Parameter 
(unit) 
 
Collection Date 
(day) [a] 
 
Was Blood 
Sample 
Collected? 
 
Value [b] 
 
Normal 
Range 
 
Overall 
Evaluation 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
xx 
xxx/xx 
Screening 
Hematocrit 
DDMMMYYYY (xx) 
Yes 
xxx.xxx B 
xxx - xxx 
Normal 
 
 
   
 
 
Week 8 
Hematocrit 
DDMMMYYYY (xx) 
Yes 
xxx.xxx 
xxx - xxx 
Normal 
 
 
   
 
 
Week 24 
Hematocrit 
DDMMMYYYY (xx) 
Yes 
xxx.xxx 
xxx - xxx 
Abnormal not clinically significant 
 
 
ETV 
: 
: 
: 
: 
: 
: 
 
 
   
 
 
: 
: 
: 
: 
: 
: 
: 
 
 
   
 
 
Screening 
Hemoglobin 
DDMMMYYYY (xx) 
Yes 
xxx.xxx A 
xxx - xxx 
: 
 
 
   
 
 
Week 8 
Hemoglobin 
DDMMMYYYY (xx) 
Yes 
xxx.xxx 
xxx - xxx 
: 
 
 
   
 
 
Week 24 
Hemoglobin 
DDMMMYYYY (xx) 
Yes 
xxx.xxx 
xxx - xxx 
Abnormal not clinically significant 
 
 
: 
: 
: 
: 
: 
: 
: 
 
 
   
 
 
: 
: 
: 
: 
: 
: 
 
 
 
   
 
 
 
Continue for all Hematology parameters 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
[a] Relative to the day of first dose of study treatment group 
[b] B=Below, A=Above the normal limits  
Programming Notes: 
 
Include Hematocrit, Hemoglobin, White Blood Cell Count with Differential (Eosinophils,  
Basophils, Lymphocytes, Neutrophils, Monocytes), Erythrocytes, Thrombocytes, Mean Corpuscular Volume (MCV), Mean 
Corpuscular hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration(MCHC) 
Program Name:                                  Date Generated:                                               Page x of y 
 
 
Repeat for the following displays: 
Listing 16.2.8.3 
Laboratory Findings - Serum Chemistry Safety Population 
  Add:  
    Note to Programmer: Include Alanine aminotranferase (ALT), Aspartate aminotranferase (AST), Total Bilirubin, Total Cholesterol, Triglycerides, 
Gamma-Glutamyltransferase (GGT), Alkaline phosphatase, Albumin, Total protein  
Glucose, Creatinine, Globulin, Calcium, Potassium, Chloride,Testosterone, Sodium, Inorganic Phosphorus, Uric acid, Urea 
  Delete:  
    Note to Programmer: Include Hematocrit, Hemoglobin, White Blood Cell Count with Differential (Eosinophils,  
Basophils, Lymphocytes, Neutrophils, Monocytes), Erythrocytes, Thrombocytes, Mean Corpuscular Volume (MCV), Mean Corpuscular hemoglobin (MCH), 
Mean Corpuscular Hemoglobin Concentration(MCHC) 
 
 


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Listing 16.2.8.4 
Laboratory Findings - Urinalysis 
Safety Population 
 
Treatment group: Treatment 1 
 
Site 
 
Patient/Age 
 
 
Nominal 
Visit 
 
Laboratory 
Parameter 
(unit) 
 
Collection 
Date (day) [a] 
 
Was Urine 
Sample 
Collected? 
 
Value  
 
 
Overall 
Inspection 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
xx 
xxx/xx 
Screening 
PH 
DDMMMYYYY (xx) 
Yes 
xxx 
 
Normal 
 
 
   
 
 
Week 8 
PH 
DDMMMYYYY (xx) 
Yes 
xxx 
 
Normal 
 
 
   
 
 
Week 24 
PH 
DDMMMYYYY (xx) 
Yes 
xxx 
 
Abnormal not clinically 
significant 
 
 
ETV 
: 
: 
: 
: 
 
: 
 
 
   
 
 
: 
: 
: 
: 
: 
 
: 
 
 
   
 
 
Screening 
Color 
DDMMMYYYY (xx) 
Yes 
xxx 
 
: 
 
 
   
 
 
Week 8 
Color 
DDMMMYYYY (xx) 
Yes 
xxx 
 
: 
 
 
   
 
 
Week 24 
Color 
DDMMMYYYY (xx) 
Yes 
xxx 
 
Abnormal not clinically 
significant 
 
 
: 
: 
: 
: 
: 
 
: 
 
 
   
 
 
: 
: 
: 
: 
: 
 
 
 
 
   
 
 
 
Continue for all Urinalysis parameters 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
[a] Relative to the day of first dose of study treatment group  
Programming Notes: 
 
Include Macroscopic analysis: pH, specific weight, appearance, colour, nitrites, proteins, 
glucose,urobilinogen, bilirubin, ketones, haematic pigments, leukocytes 
Microscopic analysis: leukocytes, Erythrocytes, flat cells, round cells, crystals, cylinders, mucus, bacteria 
 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.8.5 
Vital Signs 
Safety Population 
 
Treatment group: Treatment 1 
 
Site 
 
Patient/ 
Age 
 
Nominal 
Visit 
 
 
Collection 
Date (day) [a] 
 
Height 
(cm) 
 
Weight 
(kg) 
 
BMI 
(kg/m2) 
 
SBP 
(mmHg) 
 
 
DBP 
(mmHg) 
 
Pulse  
(bpm) 
 
Temperature 
(C) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
Screening  
DDMMMYYYY(xx)  
xxxxx 
xxxxxx 
xxxx 
xxxx     xxxx      xxxx 
  xxx 
 
 
 
 
Week 24 
 
DDMMMYYYY(xx) 
xxxxx 
xxxxxx 
xxxx 
xxxx     xxxx 
  xxxx 
  xxx 
 
 
 
 
Week 28 
 
DDMMMYYYY(xx) 
xxxxxx 
xxxxxx 
xxxx 
xxxx     xxxx 
  xxxx 
  xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a]  Relative to the day of first dose of study treatment group 
Note: Body temperature is reported in Celsius. For those patients who reported their body temperature in Fahrenheit. The following 
coversion will be used: T(°C) = (T(°F) - 32) × 5/9  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient and visit. 
 
Temperature is collected in 2 units. Please convert F to C. T(°C) = (T(°F) - 32) × 5/9 
Program Name:                                  Date Generated:                                               Page x of y 


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Listing 16.2.8.6 
Physical Examination Results 
Safety Population 
 
Treatment group: Treatment 1 
 
Site 
Patient/
Age 
 
Visit 
Assessment Date (day) 
[a] 
 
Body System 
Abnormalities 
 
Findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xx 
xxx/xx 
Baseline 
DDMMMYYYY (xx) 
 
Cardiovascular 
xxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Respiratory 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Gastrointestinal 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Skin 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Musculoskeletal 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Endocrine 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Neurological 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HEENT 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Genitourinary 
xxxxxxxxxxxxxxxxxxx
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
Week x 
DDMMMYYYY (xx) 
 
None 
Patient refusal
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
[a]  Relative to the day of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient and visit. Only present abnormal body systems. If all 
body systems are normal at a visit, output “None” in Body System Abnormalities column for the visit. 
 
If PE is not performed, please display "No PE performed" under Body System Abnormalities column and report reason not performed 
under "Findings" column. 
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Listing 16.2.8.7 
Self-administered Sexual Dysfunction Questionnaire 
Safety Population 
 
Treatment group: Treatment 1 
 
Site 
Patient/
Age 
 
Visit 
Assessment Date (day) 
[a] 
 
 
Question: Over the past 4 weeks 
 
Answer 
 
 
 
 
 
 
 
xx 
xxx/xx 
Week 4 
DDMMMYYYY (xx) 
 
How often were you able to get an erection during 
sexual activity? 
No sexual activity 
 
 
 
 
 
When you had erections with sexual stimulation, how 
often were your erections hard enough for 
penetration? 
Almost always or 
always 
 
 
 
 
 
When you attempted sexual intercourse how often were 
you able to penetrate (enter) your partner? 
Most times 
 
 
 
 
 
During sexual intercourse how often were you able to 
maintain your erection after you had penetrated 
(entered) your partner? 
Did not attempt 
intercourse 
 
 
 
 
 
During sexual intercourse how difficult was it to 
maintain your erection to completion of intercourse? 
Slightly difficult 
 
 
 
 
 
: 
: 
 
 
 
 
 
: 
: 
 
 
 
 
 
 
 
 
 
Week 8 
DDMMMYYYY (xx) 
 
How often were you able to get an erection during 
sexual activity? 
No sexual activity 
 
 
 
 
 
: 
: 
 
 
 
 
 
: 
: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[a] Relative to the day of first dose of study treatment group  
Programming Notes: 
 
Repeat for all treatment groups. Sort by treatment group, site, patient and visit.  
Program Name:                                  Date Generated:                                               Page x of y 
 
 


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Figure 14.1.6 
Study Treatment Compliance 
ITT Population 
 
  
 
Program Name:                                  Date Generated:                                               Page x of y 
40
50
60
70
80
90
100
Compliance %
Spray 
 (Diary)
Bottle 
 (Diary)
Spray 
 Returned
Bottle 
 Returned
Spray 
 (Diary)
Bottle 
 (Diary)
Spray 
 Returned
Bottle 
 Returned
Spray 
 (Diary)
Bottle 
 (Diary)
Spray 
 Returned
Bottle 
 Returned
P-3074 + P
Vehicle + P
Vehicle + FNS


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Figure 14.2.1.1 
Hair Count Unadjusted Mean Change From Baseline by Treatment Over Time 
ITT Population 
 
 
 
 
 
 
 
 
Note: Vertical bar represents 95% CI.  
 
Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Figure 14.2.1.2 
Hair Count Adjusted Mean Change From Baseline by Treatment Over Time ITT Population 
 
Figure 14.2.2.1 
Hair Count Unadjusted Mean Change From Baseline by Treatment Over Time PP Population 
 
Figure 14.2.2.2 
Hair Count Adjusted Mean Change From Baseline by Treatment Over Time PP Population 
 
Figure 14.2.3.1 
Hair Width Unadjusted Mean Change From Baseline by Treatment Over Time ITT Population 
 
Figure 14.2.3.2 
Hair Width Adjusted Mean Change From Baseline by Treatment Over Time ITT Population 
 
-0.5
0.0
0.5
1.0
1.5
2.0
Time points
Unadjusted Mean Change from Baseline
Baseline
Week 12
Week 24
P-3074+P
Vehicle + P


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Figure 14.2.4.1 
Hair Width Unadjusted Mean Change From Baseline by Treatment Over Time PP Population 
 
Figure 14.2.4.2 
Hair Width Adjusted Mean Change From Baseline by Treatment Over Time PP Population 
 
 


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Figure 14.2.8.1 
Unadjusted Investigator Assessment of Improvement Patient Hair Growth/Loss Mean Score from Baseline by Treatment Over Time 
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Program Name:                                  Date Generated:                                               Page x of y 
Repeat for the following displays: 
Figure 14.2.8.2 
Adjusted Investigator Assessment of Improvement Patient Hair Growth/Loss Mean Score from Baseline by Treatment Over Time 
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Figure 14.2.9.1 
Unadjusted Investigator Assessment of Improvement Patient Hair Growth/Loss Mean Score from Baseline by Treatment Over Time 
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Figure 14.2.9.2 
Adjusted Investigator Assessment of Improvement Patient Hair Growth/Loss Mean Score from Baseline by Treatment Over Time 
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