Clinical trial NCT04110054
Conditions: Chronic Cough
Keywords: P2X3 receptor antagonist Refractory chronic cough S-600918
Sponsor: Shionogi
Start date: 2020-02-13; Completion date: 2020-12-28
Enrollment: 406 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.

Detailed description:

Arms: arm 1: Participants will receive 50 mg S-600918 orally once a day for 28 days. arm 2: Participants will receive 150 mg S-600918 orally once a day for 28 days. arm 3: Participants will receive 300 mg S-600918 orally once a day for 28 days. arm 4: Participants will receive placebo to S-600918 orally once a day for 28 days.
Interventions: intervention 1: S-600918 intervention 2: Placebo to S-600918
Intervention descriptions: intervention 1: Tablets for oral administration intervention 2: Tablets for oral administration

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
 Biostatistics and Programming 
Statistical Analysis Plan (SAP) Client Approval Form 
 
SOP-BST-05ar06 
Effective Date:   19 September 2019 
Page 1 of 2
Client: 
Shionogi, Inc. 
Protocol Number: 
1812VA323 
Document Description: 
Statistical Analysis Plan, Text Only 
SAP Title: 
A Phase 2b, multicenter, randomized, double-blind, 
placebo-controlled, parallel-group, dose-selection study 
of S-600918 in patients with refractory chronic cough 
SAP Version Number: 
1.2 
Effective Date: 
26-February-2021
Author(s): 
 
 
For Shionogi, Inc.: 
 
Approved by: 
Refer to the flag pages 
Refer to the flag pages 
 
 Shionogi 
& Co., Ltd. 
Date (DD-MMM-YYYY) 
Refer to the flag pages 
Refer to the flag pages 
 
 
 Shionogi & Co., 
Ltd. 
Date (DD-MMM-YYYY) 
 v1.0, SHIONOGI Vault eTMF, Generated on 02 Jun 2021
NCT #: NCT04110054


 Biostatistics and Programming 
Statistical Analysis Plan (SAP) Client Approval Form 
 
 
SOP-BST-05ar06  
Effective Date:   19 September 2019 
Page 2 of 2 
 
Reviewed by: 
Refer to the flag pages 
 
Refer to the flag pages 
 
,
 
 
Date (DD-MMM-YYYY) 
Refer to the flag pages 
 
Refer to the flag pages 
 
, Shionogi & 
Co., Ltd. 
 
Date (DD-MMM-YYYY) 
Refer to the flag pages 
 
Refer to the flag pages 
 
 
 
Shionogi & Co., Ltd. 
 
Date (DD-MMM-YYYY) 
 
 
 v1.0, SHIONOGI Vault eTMF, Generated on 02 Jun 2021


Shionogi 
 
Statistical Analysis Plan, Version 1.2 
1812VA323 
 
Date Issued: 26FEB2021 
 
  
1 of 35 
 
 
 
 
 
 
 
 
 
 
Shionogi 
 
1812VA323 
 
A Phase 2b, multicenter, randomized, double-blind, 
placebo-controlled, parallel-group, dose-selection study of 
S-600918 in patients with refractory chronic cough 
 
26FEB2021 
 
Statistical Analysis Plan 
 
Version 1.2 
 
Prepared by: 
 
 
 
 
 
 
 
 
 
 v1.0, SHIONOGI Vault eTMF, Generated on 02 Jun 2021


Shionogi 
 
Statistical Analysis Plan, Version 1.2 
1812VA323 
 
Date Issued: 26FEB2021 
 
  
2 of 35 
 
Document History – Changes compared to previous version of SAP: 
Version 
Date 
Author 
Changes from Previous Version 
1.0 
20DEC2019 
 
Original Issue 
1.1 
26JUN2020 
 
Added section 5.3 to address COVID-19 / SARS-COV-2.  
Added descriptions of Original and Latest data and handling 
for Patient Reported Outcomes in section 4. 
1.2 
22FEB2021 
 
Updated Analysis of Leicester Cough Questionnaire data in 
section 8.2.4 to account for translation error in Ukrainian.  
Updated analysis window descriptions in section 4. 
 
 
 
 
 
 
 
 
 
 
 
 v1.0, SHIONOGI Vault eTMF, Generated on 02 Jun 2021


Shionogi 
 
Statistical Analysis Plan, Version 1.2 
1812VA323 
 
Date Issued: 26FEB2021 
 
  
3 of 35 
 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ................................................................................................... 5 
1. 
INTRODUCTION ......................................................................................................... 6 
2. 
OBJECTIVES ............................................................................................................... 6 
3. 
INVESTIGATIONAL PLAN ........................................................................................ 6 
3.1. 
OVERALL STUDY DESIGN AND PLAN ............................................................................6 
3.2. 
STUDY ENDPOINTS .......................................................................................................7 
3.2.1. 
PRIMARY EFFICACY ENDPOINT .....................................................................................7 
3.2.2. 
SECONDARY EFFICACY ENDPOINTS ..............................................................................8 
3.3. 
TREATMENTS ...............................................................................................................9 
3.4. 
DOSE ADJUSTMENT/MODIFICATIONS ............................................................................9 
4. 
GENERAL STATISTICAL CONSIDERATIONS ...................................................... 9 
4.1. 
SAMPLE SIZE ............................................................................................................. 11 
4.2. 
RANDOMIZATION, STRATIFICATION, AND BLINDING .................................................... 11 
4.3. 
ANALYSIS SETS.......................................................................................................... 12 
4.3.1. 
All Randomized Population .................................................................................... 12 
4.3.2. 
Full Analysis Set (FAS) .......................................................................................... 12 
4.3.3. 
Per Protocol Set (PPS) .......................................................................................... 12 
4.3.4. 
Safety Population ................................................................................................... 12 
4.3.5. 
PK Concentration Population ................................................................................ 13 
5. 
PATIENT DISPOSITION........................................................................................... 13 
5.1. 
DISPOSITION .............................................................................................................. 13 
5.2. 
PROTOCOL DEVIATIONS ............................................................................................. 13 
5.3. 
COVID-19 / SARS-COV-2 ....................................................................................... 13 
6. 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS.................................. 13 
6.1. 
DEMOGRAPHICS ......................................................................................................... 13 
6.2. 
BASELINE DISEASE CHARACTERISTICS ....................................................................... 14 
6.3. 
SMOKING HISTORY .................................................................................................... 14 
6.4. 
MEDICAL HISTORY .................................................................................................... 14 
6.5. 
INCLUSION AND EXCLUSION CRITERIA ........................................................................ 14 
7. 
TREATMENTS AND MEDICATIONS ..................................................................... 14 
7.1. 
PRIOR, CONCOMITANT, AND RESTRICTED MEDICATIONS ............................................. 14 
7.1.1. 
Prior Medications .................................................................................................. 15 
7.1.2. 
Concomitant Medications ...................................................................................... 15 
7.1.3. 
Restricted Medications ........................................................................................... 15 
7.2. 
STUDY TREATMENTS ................................................................................................. 15 
7.2.1. 
Study Drug Exposure ............................................................................................. 15 
7.2.2. 
Treatment Compliance ........................................................................................... 16 
8. 
EFFICACY ANALYSIS.............................................................................................. 16 
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8.1. 
PRIMARY EFFICACY ENDPOINT ................................................................................... 16 
8.1.1. 
Primary Analysis ................................................................................................... 17 
8.1.2. 
Sensitivity Analyses of the Primary Endpoint ......................................................... 17 
8.1.3. 
Supplementary Analyses of the Primary Endpoint .................................................. 17 
8.1.4. 
Other Analyses of the Primary Endpoint ................................................................ 17 
8.2. 
ANALYSIS OF SECONDARY EFFICACY ENDPOINTS ....................................................... 18 
8.2.1. 
Analysis of Cough Counts while Awake / Asleep .................................................... 18 
8.2.2. 
Analysis of Cough Count Reduction Thresholds ..................................................... 19 
8.2.3. 
Analysis of Cough Severity (VAS)........................................................................... 19 
8.2.4. 
Analysis of Leicester Cough Questionnaire (LCQ) Score ....................................... 19 
8.2.5. 
Analysis of International Consultation on Incontinence Modular Questionnaire-
Short Form (ICIQ-SF) Score............................................................................................... 20 
8.2.6. 
Analysis of Short Form 36, Version 2 (SF-36v2) Scores ......................................... 20 
8.2.7. 
Analysis of Patient Global Impression of Change (PGIC) ...................................... 20 
8.3. 
OTHER EFFICACY ANALYSES...................................................................................... 20 
8.3.1. 
Analysis of Cough Recording Completeness ........................................................... 20 
9. 
SAFETY ANALYSIS .................................................................................................. 20 
9.1. 
ADVERSE EVENTS ...................................................................................................... 21 
9.1.1. 
Incidence of Adverse Events ................................................................................... 21 
9.1.2. 
Relationship of Adverse Events to Study Drug ........................................................ 21 
9.1.3. 
Severity of Adverse Event ....................................................................................... 21 
9.1.4. 
Serious Adverse Events .......................................................................................... 21 
9.1.5. 
Adverse Events Leading to Treatment Discontinuation ........................................... 21 
9.1.6. 
Death ..................................................................................................................... 21 
9.1.7. 
Subgroup Analyses for Adverse Events ................................................................... 21 
9.1.8. 
Taste Changes ....................................................................................................... 22 
 
 
9.2. 
CLINICAL LABORATORY EVALUATIONS ...................................................................... 22 
9.3. 
VITAL SIGN MEASUREMENTS ..................................................................................... 23 
9.4. 
PHYSICAL EXAMINATION ........................................................................................... 23 
9.5. 
ELECTROCARDIOGRAM .............................................................................................. 23 
10. 
PHARMACOKINETICS ............................................................................................ 23 
11. 
PHARMACODYNAMICS .......................................................................................... 24 
12. 
INTERIM ANALYSIS ................................................................................................ 24 
13. 
CHANGES IN THE PLANNED ANALYSIS............................................................. 24 
14. 
APPENDICES ............................................................................................................. 25 
14.1. 
APPENDIX 1: SCHEDULE OF STUDY PROCEDURES ........................................................ 25 
14.2. 
APPENDIX 2: HANDLING OF COUGH COUNTS .............................................................. 34 
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List of Abbreviations 
AE 
adverse event 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BMI 
body mass index 
Cmax 
maximum plasma drug concentration 
CMH 
Cochran-Mantel-Haenszel 
CRF 
case report form 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
Ctrough 
trough plasma concentration 
CV% 
coefficient of variation 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FEV1 
forced expiratory volume in 1 second 
FU 
follow-up 
FVC 
forced vital capacity 
ICIQ-SF 
International Consultation on Incontinence Modular Questionnaire-Short Form 
ie 
that is 
IRT 
Interactive Response Technology 
LCQ 
Leicester Cough Questionnaire 
MCS 
mental components summary 
MedDRA 
Medical Dictionary for Regulatory Activities 
PCS 
physical components summary 
PGIC 
Patient Global Impression of Change 
PK 
pharmacokinetic(s) 
PPS 
per protocol set 
PRO 
patient reported outcome 
PT 
preferred term 
PT-INR 
prothrombin time international normalized ratio 
S-600918 
a selective P2X3 receptor antagonist 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SF-36 
Short Form (36) Health Survey 
SI 
International System of Units 
SMQ 
Standardized MedDRA Query 
SOC 
system organ class 
TEAE 
treatment-emergent adverse events 
US 
United States Customary Units 
VAS 
Visual Analog Scale 
WHO 
World Health Organization 
x ULN 
times the upper limit of the normal reference range 
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1. Introduction 
 
This is a Phase 2b study of S-600918 for the treatment of refractory chronic cough.  Coughing is a 
defense mechanism that eliminates sputum and foreign bodies from the airways.  Chronic cough is 
defined as cough that persists for ≥ 8 weeks.  Refractory chronic cough is further defined as a chronic 
cough after the patient is treated for an underlying medical condition, as well as chronic cough for which 
an underlying medical condition has not been identified despite appropriate patient evaluation.  An 
estimated 2% to 5% of the population of Europe, the United States, and Japan suffers from refractory 
chronic cough.  There are currently no drugs approved for the treatment of refractory chronic cough.   
 
S-600918 is a P2X3 receptor antagonist developed by Shionogi & Co., Ltd that is formulated for once 
daily oral administration.  In previous studies, this class of drugs has shown an effect in suppressing the 
cough reflex among patients with refractory chronic cough.  Four previous studies of S-600918 have been 
completed, including a phase 1 single ascending dose & food effect study, a phase 1 multiple ascending 
dose study, a Phase 1 drug-drug interaction study, and a phase 2 crossover study in refractory chronic 
cough patients.  The data from these studies has informed the design of Study 1812VA323 (this VA323 
study) and are discussed in further detail in section 1.2.2 of the protocol.   
2. Objectives 
 
The Primary Objective of this study is to determine the optimal dose of S-600918 in patients with 
refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per 
hour) with S-600918 compared with placebo. 
 
The secondary objectives are: 
• 
To compare the efficacy of S-600918 to that of placebo in patients with refractory chronic cough 
based on the following measurements: 
o 
Number of coughs per hour while awake 
o 
Number of coughs per hour while asleep 
o 
Severity of cough as assessed by the patient on the Visual Analog Scale (VAS) 
o 
Leicester Cough Questionnaire (LCQ) 
o 
International Consultation on Incontinence Modular Questionnaire-Short Form (ICIQ-SF) 
o 
Short Form (36) Health Survey (SF-36), version 2 
o 
Patient Global Impression of Change (PGIC) 
• 
To evaluate the safety of S-600918 in patients with refractory chronic cough. 
• 
To assess the pharmacokinetics (PK) of S-600918 and its metabolite (S-600918 acyl glucuronide) 
in patients with refractory chronic cough. 
3. Investigational Plan 
3.1. Overall Study Design and Plan 
 
This VA323 study is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-
group, dose-selection study of 3 doses of S-600918 in patients with refractory chronic cough.  A total of 
372 patients are planned to be randomized in a 1:1:1:1 manner to either placebo, S-600918 50mg, S-
600918 150mg, or S-600918 300mg, stratified by region (United States, Europe, Japan) and by hourly 
cough count based on the 24-hour cough count recording at Visit 1 (≥30 coughs/hour or <30 
coughs/hour).  The study duration for each patient is 8-10 weeks, with 18-28 days in screening (Visit 1 
and 2), 28 days of treatment (Visit 3, 4, 5, and 6), and 14 days of follow-up (Visit 7) planned.  Planned 
efficacy assessments will be cough counts, as measured by a VitaloJAK cough monitor, and several 
patient report outcomes & questionnaire responses, including weekly cough severity (VAS), LCQ, ICIQ-
SF, SF-36, and PGIC.  Further clinical assessments include, but are not limited to laboratory samples, 
vital signs, electrocardiogram (ECG), physical examinations, adverse events, concomitant medications, 
and pharmacokinetic samples.  A detailed description of study assessments by visit can be found in 
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section 8 of the protocol, with a tabular summary given in Appendix 1 of the protocol which is also 
available within this SAP as Appendix 1. 
 
Figure 3-1 
 
3.2. Study Endpoints 
3.2.1. Primary Efficacy Endpoint 
The primary efficacy endpoint is the ratio of the average number of coughs per hour in 24 hours (based 
on cough counts recorded by the VitaloJAK cough monitor) after administration of study drug for 4 weeks 
to that at baseline.  For cough count data, baseline is defined as the last non-missing observation prior to 
the initiation of study treatment.  As such, a ratio value that is below 1 will represent a reduction in cough, 
while a value above 1 will represent an increase in cough. 
 
The VitaloJAK cough monitor has European Conformity (CE) marking in the European Union and 510(k) 
approval from the United States Food and Drug Administration (FDA).  It is widely used in global studies 
and consists of a microphone and a recording device and was designed to acquire, record, and store 
ambulatory cough sounds for up to 24 hours.  The VitaloJAK cough monitor does not measure the 
intensity or the impact of cough. 
 
In this study, the VitaloJAK cough monitor will be applied to patients at Visit 1 (Screening), Visit 2 (Day -
1), Visit 4 (Day 8), Visit 5 (Day 22), and Visit 6 (Day 27).  On each of these visit days, patients will be 
instructed to wear the monitor continuously for 24 hours.  Patients will then remove the monitor and return 
it to the site.  The site will upload the data from the cough monitor to Vitalograph, the cough monitor 
analysis institution.  The data will be analyzed by cough analysis technicians and provided for further 
statistical analysis.  The cough data provided for statistical analysis will contain a chronological log of 
coughs, sleep, wake, and recording times while each of awake and asleep.  From this, the average 
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coughs per hour in the 24 hours following the activation of the cough monitor will be calculated based on 
the recording time. 
 
3.2.2. Secondary Efficacy Endpoints 
The secondary efficacy endpoints include several more representations of the cough counts from the 
VitaloJAK monitor, as well as scores from several patient-reported outcomes captured via questionnaire 
or electronic device. 
 
For the cough counts, the secondary efficacy endpoints further explore the ratio of the reduction while 
awake and while asleep, as well as binary measures of whether patients achieved a 30%, 50%, and 70% 
reduction threshold.  These are: 
 
• 
A reduction from baseline in the number of coughs per hour in 24 hours by ≥30%, ≥ 50%, and 
≥70% 
• 
The ratio of the number of coughs per hour while awake after administration of study drug for 4 
weeks to that at baseline. 
• 
A reduction from baseline in the number of coughs per hour while awake by ≥30%, ≥ 50%, and 
≥70% 
• 
The ratio of the number of coughs per hour while asleep after administration of study drug for 4 
weeks to that at baseline. 
 
Further secondary endpoints draw from the results of several questionnaires or instruments reported 
during the study.  The relevant endpoints are listed below: 
 
• 
The change from baseline in weekly cough severity as assessed on the Visual Analog Scale 
(VAS) via the electronic tablet 
• 
The change from baseline through Day 7 in daily cough severity as assessed on the VAS via the 
eDiary  
• 
The change in Leicester Cough Questionnaire (LCQ) total score from baseline 
• 
Whether or not the patient achieved an increase of ≥ 1.3 points (ie, improvement) in the LCQ total 
score from baseline  
• 
The change in ICIQ-SF score from baseline 
• 
The change in SF-36 (version 2) Physical Component Summary (PCS) and Mental Component 
Summary (MCS) scores from baseline, and the change from baseline in each of the 8 domain 
scores. 
• 
The Patient Global Impression of Change (PGIC) 
 
The VAS will be presented as a numerically labelled linear scale from 0-100 mm, where the patient is 
asked to indicate the severity of the cough.  Higher VAS scores correspond to higher cough severity.  The 
weekly cough severity will be captured at Visits 1, 2, 4, 5, and 6, and/or at the time of discontinuation of 
study drug, via an electronic tablet.  The daily cough severity will be captured via an eDiary issued to 
patients from Visit 1 until Visit 4. 
 
The LCQ is a quality of life measure of chronic cough.  The questionnaire contains 19 items across 3 
domains (physical, psychological, and social) to which the patient responds on a 7-point Likert response 
scale.  The total score can range from 3 to 21 and domain scores can range from 1 to 7.  Higher scores 
indicate a better quality of life.  The LCQ will be completed at Visits 1, 2, 4, 5, and 6, and/or at the time of 
discontinuation of study drug.  
 
The International Consultation on Incontinence Modular Questionnaire-Short Form (ICIQ-SF) is a 
questionnaire used to evaluate the frequency, severity, and impact of urinary incontinence on the quality 
of life.  The questionnaire includes 3 items with responses measured on Likert scales, and one item that 
is measured via a qualitative response.  The three nominal responses are summed to give the ICIQ score 
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(this total ICIQ-SF score can range from 0 to 21).  The ICIQ-SF will be completed at Visit 2 and Visit 6, 
and/or at the time of discontinuation of study drug. 
 
The Short-Form 36 (SF-36) Questionnaire is a widely used patient reported measure of overall health.  
The questionnaire consists of 8 scaled scores (health concepts) and evaluates vitality, physical 
functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, 
social role functioning, and mental health. Scores for each scale range from 0 to 100; the lower the score, 
the greater the disability.  The SF-36 measurements can be further characterized by 2 summary scores: 
the Physical Component Summary (PCS) and the Mental Component Summary (MCS).  The SF-36 will 
be completed at Visit 2 and Visit 6, and/or at the time of discontinuation of study drug. 
 
The Patient Global Impression of Change is a single-item questionnaire based on the Clinical Global 
Impression – Improvement scale, and it collects the patient’s impression of overall improvement at Visit 6 
and/or, if applicable, at the time of discontinuation of study drug.  Responses are given on a 7-point Likert 
Scale, with lower scores indicating increasing degrees of improvement (1-3), 4 indicating no change, and 
higher scores indicating increasing degrees of worsening (5-7). 
3.3. Treatments 
 
S-600918 is formulated as a 50-mg orange, film-coated tablet.  The placebo used in this study matches 
the S-600918 50-mg tablet in appearance.  Patients will receive study treatment with S-600918 50 mg, S-
600918 150 mg, S-600918 300 mg, or matching placebo, as follows: 
 
• 
S-600918 50-mg group: 1 x 50-mg tablet and 5 placebo tablets once daily 
• 
S-600918 150-mg group: 3 x 50-mg tablets and 3 placebo tablets once daily 
• 
S-600918 300-mg group: 6 x 50-mg tablets once daily 
• 
Placebo group: 6 x placebo tablets once daily 
 
Treatment will be dispensed to patients at Visit 3 (Day 1), Visit 4 (Day 8), and Visit 5 (Day 22).  
Treatments will be packaged in identical blister cards within a wallet that will each contain 7 days of 
treatment plus 3 days of extra study drug in the event the patient cannot return for the next visit as 
scheduled.  One wallet will be dispensed at Visit 3 and at Visit 5, and two wallets will be dispensed at Visit 
4.    
3.4. Dose Adjustment/Modifications 
 
No dose adjustments or modifications are allowed in this study. 
4. General Statistical Considerations 
 
Unless otherwise noted, continuous variables will be summarized based on the number of non-missing 
observations (N), arithmetic mean (Mean), standard deviation (SD), median, minimum, and maximum 
values. Categorical variables will be summarized based on the frequency count and the percentage of 
patients in each category.  All statistical tests will be performed at the 0.05 significance level using 2-
sided tests, unless otherwise noted, and statistical testing will not be adjusted for multiple comparisons. 
 
Study data will be presented in by-patient data listings. In general, all tables will be presented by 
treatment group. Individual patient data, PK data, and any derived data will be presented by treatment 
group (study drug) (S-600918 50 mg, S-600918 150 mg, S-600918 300 mg, and placebo). All analyses 
and tabulations will be performed by using SAS Version 9.2 or higher and WinNonlin Version 6.3 or 
higher.  
 
Baseline will be defined as the last valid assessment recorded prior to the first administration of study 
drug unless otherwise specified. 
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For summaries, patients will be counted only once within each planned visit.  In these summaries, the visit 
windows will follow the windows given in the protocol, which are repeated in Appendix 1 of this SAP.  
However, +1 day will be allowed at the end of the Visit 6 time window for analysis. 
 
Table 4-1: General Analysis Visit Windows 
 
Visit 
Target Day 
Window Start Day 
Window End Day 
Visit 1 / Screening 
-18 
-28 
-18 
Visit 2 / Day -1 
-1 
-1 
-1 
Visit 3 / Day 1 
1 
1 
1 
Visit 4 / Day 8 
8 
6 
10 
Visit 5 / Week 3 
22 
20 
24 
Visit 6 / Week 4 
27 
25 
28 
 
In the event that more than one observation is recorded within one of these windows, then, among these 
records within the window, the record occurring at the planned visit in the CRF will be used.  If no records 
occurred at the planned visit within the window, then records occurring at any unplanned visits within the 
visit window will be considered, and the record occurring closest in time to the target visit day will be 
used.  Results that are recorded at an Early Discontinuation visit may be summarized at a planned visit if 
the Early Discontinuation visit falls within the window for the planned visit, and the planned visit has not 
occurred. 
 
Study days will be calculated using the date of the first administration of study drug as follows: 
 
• 
If the assessment occurs on or after the date of the first administration of study drug, 
study day = (date of assessment – date of first administration of study drug) + 1 
• 
If the assessment occurs prior to the date of the first administration of study drug, 
study day = date of assessment – date of first administration of study drug 
 
Summaries presented by visit will only present the visits for which the parameter was planned to be 
collected.  Listings of data collected at study visits will include all such data, regardless of whether it was 
planned to be collected during that visit. 
 
Certain regional guidelines provide that patient reported outcomes (PROs) can be re-entered, or 
corrected, by the patient after the initial entry. This study uses several PROs, such as VAS, LCQ, ICIQ-SF, 
SF-36, PGIC, and Taste Questionnaire.  As such when the original data are corrected, analyses will be 
conducted that use the latest available corrected data.  For patients who did not correct their original entry, 
their original entry will be used in these analyses of corrected data.  Additional analyses of only the 
original data will also be performed. 
 
The following conventions define how the original data and corrected data will be analyzed.  If there are 
no data corrections, then these conventions do not apply. 
 
Analyses on the full analysis Set will use the latest corrected data, regardless of when the correction was 
obtained.  A footnote to all tables containing corrected data will note how many instances of corrected 
data were included.  These analyses will be included in the body of the CSR and will be the basis of 
hypothesis testing. 
 
These analyses will be repeated using the original entries.  Any differences in inference between the 
analysis of the corrected data and analysis of the original data will be noted in the CSR. 
 
There is no plan for analyzing the PRO data using a Per Protocol Set.  However, if this plan changes 
during or after the study, the Per Protocol Set will use corrected data only if the corrected data falls within 
the protocol defined window for a visit.  Corrected data collected outside a visit window will not be 
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included in the Per Protocol Set population.  A supplemental Per Protocol Set analysis will be conducted 
using only the original collected data.  Any difference in the conclusions based on the Per Protocol Set 
between the use of the original and corrected data will be noted in the CSR if the CSR has not yet been 
completed. 
 
In principle, missing data will not be imputed.  
4.1. Sample Size 
 
The sample size has been determined using the results of the VA322 proof-of-concept study.  In that 
VA322 study, the mean (± SD) of the common log-transformed ratio of cough frequencies per hour in 24 
hours after 2 weeks of treatment to that at baseline was −0.327 (0.379) in the S-600918 150-mg 
treatment (N = 31) and −0.160 (0.363) in the placebo treatment (N = 30). The difference in the common 
log-transformed ratio of the cough frequencies per hour in 24 hours after 4 weeks of treatment to that at 
baseline between each S-600918 dose group and placebo and the standard deviation (SD) in each 
treatment group in the Phase 2b study were assumed to be the same as those after 2 weeks of treatment 
observed in the proof-of-concept study, and −0.163 and 0.371, respectively. As a result, the effect size, 
ie, the difference divided by the SD, was determined to be −0.44. Based on this assumption, the sample 
size required to assure 80% power with a 2-sided 5% level of significance was calculated to be 83 
patients per treatment group. Allowing for exclusion of 10% of patients per treatment group, 93 patients 
per treatment group will be needed. Therefore, the planned sample size at randomization was determined 
to be a total of 372 patients. 
 
 
4.2. Randomization, Stratification, and Blinding 
 
Patients who meet screening criteria at Visit 3 will be randomized in a 1:1:1:1 allocation to the 4 treatment 
groups (described in detail in section 3.3).  The randomization will be stratified based on region (Japan, 
Europe, or the United States) and hourly cough count based on the 24-hour cough count recording at 
Visit 1 (≥30 coughs/hour or <30 coughs/hour) and will be performed by Interactive Response Technology 
(IRT). 
 
The study will be conducted in a double-blind manner. Placebo tablets will match in appearance the S-
600918 50-mg tablet, and the labeling and packaging of S-600918 and placebo will be identical.  Section 
3.3 of this SAP describes how treatment is packaged to achieve the dose-levels of S-600918 used in this 
study. 
 
The randomization schedule will be maintained by IRT until data lock, as specified in the IRT User 
Manual. Except for unblinded sponsor staff (e.g., the Investigational Medicinal Product Manager) or 
designees, the sponsor and the sponsor’s designees, the investigator, and all study-site personnel will be 
blinded to treatment assignment until data lock. As plasma drug concentration data may reveal the study 
treatment to which a patient was randomized, only the sponsor’s bioanalytical expert will be provided 
these data prior to data lock to determine whether the bioanalysis is conducted appropriately.  After data 
lock of all eCRF data, the sponsor will obtain the randomization schedule and all data from the IRT.   
 
Unblinding at the request of an investigator should occur only in the event of an emergency, pregnancy of 
a patient, or an adverse event for which it is necessary to know the study drug to determine an 
appropriate course of therapy. Prior to unblinding and if the situation allows it, the investigator should 
contact the Medical Monitor. If the investigator judges it necessary to know the randomization code for a 
specific patient, the investigator will obtain the randomization code through the IRT, which will capture (at 
a minimum) the date and time of unblinding and the reason for unblinding. If the investigator is unable to 
speak with the Medical Monitor prior to unblinding, the investigator must notify the site monitor or the 
Medical Monitor as soon as possible after unblinding, WITHOUT revealing the treatment assignment for 
that patient. Procedures for emergency unblinding are specified in the IRT User Manual. The patient 
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should remain in the study and complete all study events and activities after unblinding, even if treatment 
is discontinued. 
 
Patients who are unblinded at the request of an investigator will be summarized and listed and described 
in the Clinical Study Report (CSR). 
4.3. Analysis Sets 
 
The analysis sets define the groups of patients that will be analyzed and presented in the tables, listings, 
and figures that are described in this SAP.  Patients will be listed along with their inclusion or exclusion in 
each of the analysis sets defined in this section. 
4.3.1. All Randomized Population 
The all randomized population will include all patients who are randomized to a treatment.  Presentations 
based on this set of patients will group patients according to their randomized treatment. 
4.3.2. Full Analysis Set (FAS) 
The FAS will include all randomized patients who receive at least 1 dose of study drug and who have 
accepted cough monitor assessment at both baseline and at least 1 visit after initiation of study drug.  
Presentations based on this set of patients will group them according to their randomized treatment.  The 
primary efficacy analysis will be performed on the full analysis set as well as the per protocol set (below).  
The primary hypothesis will be tested using the FAS.  Patients in the all randomized population who fail to 
meet these criteria for entry in to the FAS will be listed with their reason(s) for exclusion from the FAS. 
4.3.3. Per Protocol Set (PPS) 
The PPS will include all randomized patients who are included in the FAS, provided they: 
 
• 
Meet all inclusion criteria affecting the evaluation of efficacy 
• 
Meet no exclusion criteria affecting the evaluation of efficacy 
• 
Do not have any major protocol deviations affecting the evaluation of efficacy (as defined in the 
Study Deviation Rules Document) 
• 
Do not use any prohibited therapy affecting the evaluation of efficacy during the study 
 
The criteria above represent an adherence to the specifications of the protocol with regards to efficacy 
assessments.  The details of the rules used to make the determination of which criteria affect the 
evaluation of efficacy will be provided in a separate document that will be reviewed by study personnel at 
the sponsor.  The first version of this Study Deviation Rules Document will be completed and signed off 
prior to the first patient being randomized.  This document will be finalized prior to unblinding.  Patients 
who receive any dose of the incorrect study drug will not be included in the PPS.  Prohibited therapies will 
be assessed by a medical review to determine whether they affect the evaluation of efficacy.  This review 
will be finalized prior to final unblinding. 
 
Presentations based on this set of patients will group them according to their randomized treatment.  
Supplementary analyses will be performed on the PPS.  Patients in the FAS who fail to meet these 
criteria for entry in to the PPS will be listed with their reason(s) for exclusion from the PPS.   
4.3.4. Safety Population  
The safety population will include all randomized patients who receive at least 1 dose of study drug.  
Presentations based on this set of patients will group them according to the first study treatment they are 
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4.3.5. PK Concentration Population 
The PK concentration population will include all patients who receive at least 1 dose of S-600918 and 
have at least 1 evaluable concentration.  Presentations based on this set of patients will group them 
according to the treatment received. 
5. Patient Disposition 
5.1. Disposition 
 
Among patients randomized, the number and percentage of patients who complete the study and who 
withdraw from the study, as well as the reasons leading to withdrawal, will be summarized by treatment 
group. Also, among all randomized patients, the number of patients included in each analysis population 
defined in section 4.3 will be summarized by treatment group, as well as overall.  As well as randomized 
patients, patients withdrawn from the study during screening period will be tabulated by reason of 
withdrawal and listed. 
5.2. Protocol Deviations 
 
Protocol deviations that are relevant to the analyses will be identified in a separate protocol deviations 
rules document that will be reviewed by study personnel.  During the study, these rules will be reviewed 
and instances where patients met any of the conditions will be logged in a database that will be finalized 
and locked prior to final unblinding.  Major deviations, that is those that are related to efficacy, will inform 
the per protocol set (PPS) as described in section 4.3.3.  In addition to these major deviations that result 
in the removal of patients from the PPS, the significant protocol deviations, that are required for CSR 
reporting, will be summarized and listed. 
5.3. COVID-19 / SARS-COV-2 
 
Shortly after this study began enrolling patients, the SARS-COV-2 virus, which causes coronavirus 
disease 2019 (COVID-19) was declared a global pandemic by the World Health Organization.  In 
accordance with guidances issued by regulatory agencies, study data collection has been amended for 
randomization patients to capture visits missed due to COVID-19 related reasons, and discontinuations 
due to COVID-19 related reasons.  COVID-19 related adverse events, concomitant medications, and 
medical history are collected using existing CRFs.   
 
Listings of patients who missed visits due to COVID-19 related reasons will be listed for the All 
Randomized Population.  Patients who withdraw from the study due to COVID-19 related reasons will be 
summarized and listed as described in section 5.1 Disposition, of this SAP. 
 
The anticipated impact of COVID-19 is widely regarded as unknown.  If the impact of COVID-19 on the 
conduct of this study is observed to be significant, further summaries and listings of the impact will be 
explored. 
6. Demographics and Baseline Characteristics 
All summaries of demographics and baseline characteristics described in this section will be presented for 
the FAS and for the Safety Population. 
6.1. Demographics 
 
A summary of demographics and baseline information will be presented by treatment group. The 
demographic characteristics consist of age (years) at informed consent, sex, race, and ethnicity. The 
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baseline characteristics consist of baseline height (cm), baseline weight (kg), and baseline body mass 
index (BMI) (kg/m^2). Body mass index is calculated as (body weight in kilograms) / (height in meters)2. 
 
Age, along with height, weight, and BMI at baseline, will be summarized using descriptive statistics. The 
number and percentage of patients by age category (<45, ≥45 - <65, ≥ 65), sex (Male, Female), race 
(White, Black or African American, Asian, American Indian or Alaska Native, Native Hawaiian or Other 
Pacific Islander, and Other), ethnicity (Hispanic or Latino, Not Hispanic or Latino), and region (Japan, 
Europe, and United States) will also be summarized. 
 
Patient demographic and baseline characteristics will also be presented via listings. 
6.2. Baseline Disease Characteristics 
 
Average cough counts per hour in 24 hours at Visit 1 and Visit 2 and baseline will be summarized using 
descriptive statistics by treatment group.  In addition, the weekly severity of cough (VAS) at baseline, the 
LCQ at baseline, and baseline pulmonary function test results, including FVC (L), FEV1 (L), and 
FEV1/FVC ratio will be summarized using descriptive statistics.  As well, the duration of chronic cough 
(months; ((date of screening – reported start date of chronic cough) + 1) / 30.4375) will be summarized 
using descriptive statistics by treatment group.  When part of the start date or end date is missing, 15th of 
the month for missing day and July 1st when month and day are missing will be used.   
 
Cough-related history will be recorded on the eCRF and coded using MedDRA v22.1.  The number and 
percentage of patients with any cough-related history will be summarized by treatment and overall for 
each preferred term.  Cough-related history will also be listed with the calculated duration of each history.  
For the calculation of duration, partial dates will be handled as above, using the 15th of the month for 
missing day and July 1st when month and day are missing.  Ongoing histories will use the date of 
enrollment as the end date for calculating duration. 
6.3. Smoking History 
 
Smoking history (pack-years) will be summarized categorically (0 pack-years, > 0 pack-years, > 5 pack-
years, >10 pack-years, and >15 pack-years), and using descriptive statistics by treatment group.   
6.4. Medical History 
 
Medical history, including prior and current conditions, surgeries, cough-related history, alcohol use, 
smoking, and marijuana use will be recorded on the eCRF and coded using MedDRA v22.1. The number 
and percentage of patients with any medical history will be summarized by treatment and overall for each 
system organ class and preferred term.  Medical history data will also be presented in a listing. 
6.5. Inclusion and Exclusion Criteria 
 
Randomized patients that fail to meet eligibility criteria will be listed with the inclusion or exclusion criteria 
that was not met. 
7. Treatments and Medications 
7.1. Prior, Concomitant, and Restricted Medications 
 
Prior, concomitant, and restricted medications and therapies will be coded using the WHO Drug 
Dictionary.  Prior medications will be classified as those medications that begin prior to the first 
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administration of study drug.  Concomitant medications are those medications that may have been taken 
during study treatment.  This principle applies to medications for which partial or missing start or end 
dates are recorded.  Restricted therapy is defined as any concomitant therapy for which use is permitted 
only with restrictions. 
 
For the purposes of classifying a course of treatment as prior and/or concomitant, partial start dates will 
be presumed as the earliest possible recorded date.  Start dates that are entirely missing will be 
presumed as the date of informed consent.   
 
For the purposes of classifying a course of treatment as prior and/or concomitant, partial end dates will be 
presumed as the latest possible recorded date.  Records with end dates that are entirely missing will be 
considered as prior and concomitant if the start date occurs before study treatment.  Such records with 
start dates occurring after the first dose of study treatment will be considered concomitant.   
7.1.1. Prior Medications 
 
The number and percentage of patients using any prior medications and by preferred term will be 
summarized by treatment for the FAS and the Safety Population.  Prior medications will be listed for the 
Safety Population. 
7.1.2. Concomitant Medications 
 
The number and percentage of patients using any concomitant medications and by preferred term will be 
summarized by treatment for the FAS and the Safety Population.  Concomitant medications will be listed 
for the Safety Population. 
7.1.3. Restricted Medications 
 
The number and percentage of patients using any restricted medications and by preferred term will be 
summarized by treatment for the FAS and the Safety Population.  Restricted medications will be listed for 
the Safety Population. 
 
7.2. Study Treatments 
7.2.1. Study Drug Exposure 
Duration of exposure is defined as the total number of days a patient is exposed to any study drug and 
will be presented as the total number of days from the first dose date (Day 1) to the last dose date (date 
of last dose minus the date of first dose + 1) as recorded in the clinical database. If a patient is lost to 
follow-up, but the drug accountability log confirms that the patient has taken study drug, the visit date 
following the last completed drug accountability log will be used.  If drug accountability log is missing for 
some reason, the patients will be regarded as not dosed for such duration. 
 
The duration of exposure to study drug by treatment will be summarized by treatment for the FAS and the 
Safety Population using descriptive statistics. The duration of exposure will then be classified into one of 
the following categories: > 1 day, >= 7 days, >= 14 days, >= 21 days and >= 25 days and will be 
presented as the number and percentage of patients in each duration category. 
 
The cumulative dose will be defined as the sum of the actual dose across all study days on which study 
drug was taken.  Patients who take more or less than the planned 6 tablets of study drug in a day will be 
considered to have received actual dose of (# of tablets taken / 6) for that day. Average daily dose is the 
cumulative dose divided by the duration of exposure.   The average daily dose and cumulative dose will 
be summarized by descriptive summary statistics. 
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A summary of each patient’s exposure will be presented in a listing. 
7.2.2. Treatment Compliance 
Overall study drug compliance will be calculated for each patient by evaluating how many days a patient 
takes study drug as directed while on study treatment up to and including Day 28. For each day on 
treatment, the number of tablets taken will be directly captured on the eCRF.  Days where 6 tablets are 
recorded as taken will be counted as the number of days of compliant dosing until the earliest date of day 
after the date of V6, Day 28 or date prior to the date of discontinuation.  For patients who complete 
treatment, the number of days on treatment will be calculated as (day after the date of Visit 6 – date of 
Visit 3) + 1.  For patients who prematurely discontinue treatment, the number of days on treatment will be 
calculated as (date prior to the date of discontinuation – date of Visit 3) + 1.  The number of days on 
treatment will be considered up to Day 28 – that is, the number of days on treatment will have a maximum 
value of 28.  
 
Thus, the overall study drug compliance (%) will be calculated as: 
 
 𝐶𝑜𝑚𝑝𝑙𝑖𝑎𝑛𝑐𝑒= 100 𝑥 
𝑁𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝐷𝑎𝑦𝑠 𝑜𝑓 𝐶𝑜𝑚𝑝𝑙𝑖𝑎𝑛𝑡 𝐷𝑜𝑠𝑖𝑛𝑔
𝑁𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝐷𝑎𝑦𝑠 𝑜𝑛 𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡
 
 
Where number of days on treatment is defined as in section 7.2.1.  A patient is considered to have 
demonstrated adequate compliance if overall study drug compliance is between 80% and 100%, 
inclusive.  
 
A categorical summary of whether patients were compliant (yes/no) will be presented by treatment group 
for the safety population. Summary statistics on percentage of treatment compliance as well as the 
number and percentage of patients in each compliance category (>=70%, >=80%, >=90%, 100%) will be 
presented by treatment group for the safety population. 
8. Efficacy Analysis 
 
For all efficacy analyses, baseline is defined the last assessment before first dose of study drug, unless 
otherwise noted.  All efficacy analyses will be presented for FAS, and, where noted, for the PPS.  When 
the framework described for the primary analysis (which is also used in several subsequent analyses) is 
applied to cough count data, if any patient has an average coughs per hour at any baseline or post-
baseline measurement that is zero, a correction factor of 0.1 will be added to all observed average 
coughs per hour values for all patients.  A correction factor of 0.1 is necessary because these counts are 
log-transformed for the purposes of analysis, and log10(0) is undefined.  This handling is applied in the 
same manner to average coughs per hour in 24 hours, while asleep, and while awake.  In principle, 
efficacy analyses will be based on data compliant with the analysis visit window at each visit in the 
treatment period for both of FAS and PPS (see section 4 of this SAP).  For this reason, data outside the 
analysis visit windows will be regarded as missing. 
8.1. Primary Efficacy Endpoint 
 
As described in section 3.2.1, the primary efficacy endpoint is the ratio of coughs per hour in the 24 hours 
following administration of study drug.  The cough counts will be provided based on the VitaloJAK 
recordings, following evaluation by the cough analysis technicians.  This ratio of the cough count 
observed at Visit 4, Visit 5, and Visit 6 to the cough count observed at baseline will be transformed using 
the common logarithm for the purposes of analysis.  The last planned cough recording prior to the first 
dose of study drug should occur at Visit 2, however, if the cough count at Visit 2 is missing, then 
according to the general conventions for baseline, the cough count from Visit 1 will be used as the 
baseline.  As well, in some instances, the cough recording at Visit 2 may span Visit 3 and include time 
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after the first dose of study drug.  If the end date and time of the Visit 2 cough recording is after the date 
and time of the first dose of study drug, then the cough count from Visit 1 will be used as the baseline. 
8.1.1. Primary Analysis 
 
The null hypotheses of equality between the treatment and placebo effects will be tested using a mixed 
model, containing treatment group, week (as a classification term), and the interaction between treatment 
group and week as fixed effects; patient as random effect; and region and the common logarithm of the 
frequency of coughs per hour at baseline as covariates.  In this model, the covariance structure will be 
given as unstructured, and the degrees of freedom will be derived using the Kenward-Roger method.  
Should the model fail to converge using the unstructured covariance, compound symmetry will be used.  
Using this model, the log-transformed ratio of the number of coughs per hour in 24 hours after 4 weeks of 
administration of study drug will be used to evaluate the null hypothesis at each dose level of S-600918 at 
the 2-sided alpha level of 0.05 among the FAS.  
 
The primary analysis will summarize each of these three 2-way comparisons, presenting the estimate for 
the difference of the effects of treatment at Visit 6, the 95% confidence interval for this difference, and the 
p-value based on the hypothesis and model described above.  Furthermore, the time course of the 
treatment effect for each treatment group will be plotted with the mean and 95% confidence interval. 
8.1.2. Sensitivity Analyses of the Primary Endpoint 
A sensitivity analysis of the primary efficacy endpoint will be performed on the FAS using an analysis of 
covariance containing treatment group, as factor; and region and the common logarithm of the frequency 
of coughs per hour at baseline as covariates.  It is expected that this ANCOVA will perform similarly as 
the primary analysis, using the observed data.  Thus, two sensitivity analyses using this ANCOVA model 
on the FAS will be performed: one that imputes missing observations with the last post-baseline 
observation, and that imputes the baseline cough counts per hour for missing observations. 
 
Furthermore, the primary analysis will be repeated for the FAS using 1) the protocol visit windows found 
in Table 7-2 of the Protocol, and 2) the nominal visit analysis windows presented below in Table 8-1. 
 
Table 8-1: Analysis Visit Windows for Sensitivity Analysis 
 
Visit 
Target Day 
Window Start Day 
Window End Day 
Visit 1 
-18 
-28 
-18 
Visit 2 
-1 
-1 
-1 
Visit 3 
1 
1 
1 
Visit 4 
8 
2 
14 
Visit 5 
22 
15 
24 
Visit 6 
27 
25 
Latest of Day 28, Day 
of Visit 6, and Day of 
Last Dose of Study 
Drug 
 
8.1.3. Supplementary Analyses of the Primary Endpoint 
The Primary Analysis described in section 8.1.1 and the Sensitivity Analyses described in 
section 8.1.2 will be repeated on the PPS as supplementary analyses. 
8.1.4. Other Analyses of the Primary Endpoint 
Summary statistics for the average number of coughs per hour in 24 hours at each visit will be presented 
by treatment group using the geometric mean and its 95% confidence interval for the FAS. 
 
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Subgroup analyses will be performed to evaluate the primary efficacy endpoint among subgroups of 
patients for the FAS.  For these subgroup analyses, the primary analysis method mentioned in the section 
8.1.1 will be repeated.  Within this framework, the subgroups below will be analyzed: 
 
 
1. Region (1-1: Japan, Europe, United States, 1-2: Japan, Europe and United States) 
2. Hourly cough count at baseline (≥30 coughs/hour, <30 coughs/hour) 
3. Cough count at Visit 1 (≥30 coughs/hour, <30 coughs/hour) 
4. Pulmonary/Cough History (Asthma, Cough variant asthma [CVA], Gastroesophageal reflux 
disease [GERD], Upper airway cough syndrome including postnasal drip, rhinosinusitis, and 
rhinitis [UACS], Eosinophilic bronchitis including atopic cough [EB], Sinobronchial syndrome 
[SBS], Unexplained cough, Other, and Refractory cough, i.e., other than Unexplained cough and 
Other).  A patient may have more than one pulmonary history.  Such patients will be included in 
each category by pulmonary history. 
 
A forest plot will also be provided based on the estimates for the difference of the effects of treatment at 
Visit 6 and its 95% Confidence Interval for the subgroups above.  
 
The primary analysis framework will be used to assess characteristics of the dose-response relationship 
on the primary efficacy endpoint.  The framework will be applied as originally described as well as to the 
log-transformed ratio of average coughs per hour in 24 hours following 4 weeks of treatment to that at 
baseline.  The below comparisons will be presented for each of these models. 
 
• 
Placebo versus 50 mg, 150 mg, and 300 mg S-600918 
• 
Placebo and 50 mg S-600918 versus 150 mg and 300 mg S-600918 
• 
Placebo, 50 mg, and 150 mg S-600918 versus 300 mg S-600918 
• 
Linear Trend Test across all Treatment Groups 
 
This framework above will be applied to the log-transformed ratio of average coughs per hour in 24 hours 
following 3 weeks of treatment to that at baseline, as well. 
 
Furthermore, a three-parameter Emax model will be fitted for the ratio of the average cough count per 
hour in 24 hours at Visit 6 to that at baseline minus 1 to estimate the minimum, maximum, and median 
effect of dose on response.  In this Emax model, dose will be handled in the original scale.  As well, a 
similar Emax model will be fitted for the ratio of the average cough count per hour in 24 hours at Visit 5 to 
that at baseline minus 1.  Responses will be plotted on a scatterplot and the fitted curve will be presented 
on the plot.  If this Emax model fails in convergence, other models, including a linear model may be fitted.  
8.2. Analysis of Secondary Efficacy Endpoints 
 
The model for the primary analysis described in section 8.1.1 provides the framework for the analysis of 
many of the secondary efficacy endpoints.  In such cases, the only difference will be response being 
modelled, unless otherwise noted.  For the sake of brevity, this framework will be referenced as the 
primary analysis framework.  Wherever this framework is referenced, the corresponding 95% confidence 
intervals and p-values will be presented. 
8.2.1. Analysis of Cough Counts while Awake / Asleep  
The cough counts while awake and while asleep will be provided based on the VitaloJAK recordings, 
following evaluation by the cough analysis technicians.  Like the primary efficacy endpoint, the ratio of the 
coughs per hour while awake at Visit 4, Visit 5, and Visit 6 to that at baseline, will be transformed using 
the common logarithm.  This transformed ratio of coughs per hour while awake will be analyzed using the 
primary analysis framework.  As well, the similarly transformed ration of coughs per her while asleep will 
be analyzed using the primary analysis framework for the FAS. 
 
Average hourly cough counts while awake and while asleep will be presented by treatment group at each 
visit using the geometric mean and its 95% confidence interval for the FAS. 
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8.2.2. Analysis of Cough Count Reduction Thresholds  
The proportion of patients who achieved a reduction from baseline in the number of coughs per hour in 24 
hours and while awake at Visit 6 of ≥30%, ≥50%, ≥70% will be summarized descriptively for each 
treatment group and compared between each dose level of S-600918 and placebo using a Cochran-
Mantel-Haenszel (CMH) test with strata by region (Japan, Europe, United States) and cough count at 
baseline (≥30 coughs/hour, <30 coughs/hour) for the FAS.  The odds ratio and its 95% confidence 
interval will be presented, as well.   
 
In addition, the proportion of patients who achieved a reduction from baseline in the number of coughs 
per hour in 24 hours and while awake at Visit 6 of ≥30%, ≥50%, ≥70% will be summarized descriptively 
for each treatment group by region and cough count at baseline (≥30 coughs/hour, <30 coughs/hour) for 
the FAS. 
8.2.3. Analysis of Cough Severity (VAS) 
The change in weekly cough severity at Visit 4, Visit 5, and Visit 6 to that at baseline will be analyzed 
using the primary analysis framework for the FAS.  Similarly, the change in daily cough severity from Day 
1 through Day 7 will be analyzed using the primary analysis framework for the FAS, only using Day 7 in 
place of Visit 6. 
 
Both weekly and daily cough severity will also be summarized using descriptive statistics at each planned 
assessment by treatment group for the FAS. 
8.2.4. Analysis of Leicester Cough Questionnaire (LCQ) Score 
The change from baseline at Visit 4, Visit 5, and Visit 6 of the LCQ score of each domain (Physical, 
Psychological, and Social) and the LCQ total score will be analyzed using the primary analysis framework 
for the FAS.   The proportion of patients who achieved an improvement from baseline in the LCQ Total 
Score of  ≥1.3 at Visit 6 will be summarized descriptively for each treatment group and compared 
between each dose level of S-600918 and placebo using a CMH test with strata by region (Japan, 
Europe, United States) and cough count at baseline (≥30 coughs/hour, <30 coughs/hour) for the FAS.  
The odds ratio and its 95% confidence interval will be presented, as well.  In addition, the proportion of 
patients who achieved this improvement from baseline in the LCQ Total Score will be summarized 
descriptively for each treatment group by region and cough count at baseline (≥30 coughs/hour, <30 
coughs/hour) for the FAS. 
 
As well, LCQ domain scores and total score will be summarized by treatment at each visit using 
descriptive statistics for the FAS. 
 
During the course of the study, while still fully blinded, it was discovered that a translation error occurred 
in the Ukrainian translation of the LCQ.  This error only affected the response options for question 16 and 
question 17, both of which are used in the calculation of the Psychological domain score and the Total 
score.  As a result, the handling of the Psychological domain score and LCQ total score data for 
Ukrainian patients will be different, as described below. 
 
(1) All data will be listed.  (2) The analyses of Psychological domain score and LCQ Total score data 
described in this section will be performed excluding these patients.  (3) Additional analyses of the 
Psychological domain score and LCQ Total score will be added where the responses for these Ukrainian 
patients to question 16 and question 17 are replaced by the observed mean response to the other 
questions within the Psychological Domain (questions 4, 5, 6, 12, and 13) within each patient and visit.  
These analyses will mirror those described in this section, with this added convention for these patients. 
 
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8.2.5. Analysis of International Consultation on Incontinence Modular 
Questionnaire-Short Form (ICIQ-SF) Score 
The change from baseline to in the ICIQ-SF Score will be summarized using the primary analysis 
framework for the FAS.  Given that ICIQ-SF is only collected at baseline and at Visit 6, it is not necessary 
to include the fixed effect of week and the interaction between treatment group and week as fixed effects. 
 
The 3 ordinal responses to the ICIQ-SF will be summarized using descriptive statistics at each visit by 
treatment group for the FAS. Subgroup analyses of 1) female patients and male patients and 2) patients 
with at least 1 symptom at baseline and patients with no symptoms at baseline will be conducted. 
 
As well, the non-ordinal responses to the ICIQ-SF (question 6) will be summarized by the number and 
percent of patients experiencing symptoms at each visit for the FAS.  This summary will be repeated 
within the following subgroups 1) female patients and male patients and 2) patients with at least 1 
symptom at baseline and patients with no symptoms at baseline. 
8.2.6. Analysis of Short Form 36, Version 2 (SF-36v2) Scores 
The analyses of SF-36v2 scores will use normalized scores provided by Optum, which are based on the 
2009 standard normalization scores. 
 
The change from baseline in the Physical Component Summary (PCS) score from the SF-36 responses 
will be summarized using the primary analysis framework for the FAS.  As well, the Mental Component 
Summary (MCS) score, and the 8 domain scores (see section 3.2.2) will be analyzed in the same 
manner.  Given that SF-36 is only collected at baseline and at Visit 6, it is not necessary to include the 
fixed effect of week and the interaction between treatment group and week as fixed effects. 
 
The PCS, MCS, and 8 domain scores will be summarized using descriptive statistics at baseline and at 
Visit 6 by treatment group for the FAS. 
8.2.7. Analysis of Patient Global Impression of Change (PGIC) 
The PGIC at Visit 6 will be summarized using descriptive statistics and the Van Elteren test will be applied 
to compare the PGIC at each dose level of S-600918 to placebo, with strata by region (Japan, Europe, 
United States) and cough count at baseline (≥30 coughs/hour, <30 coughs/hour).  And, proportion of 
patients with either of “Very much improved”, “Much improved” or “Minimally improved” will be compared 
between each dose level of S-600918 and placebo using a Cochran-Mantel-Haenszel (CMH) test with 
strata by region (Japan, Europe, United States) and cough count at baseline (≥30 coughs/hour, <30 
coughs/hour) for the FAS.  The odds ratio and its 95% confidence interval will be presented, as well. 
 
8.3. Other Efficacy Analyses 
8.3.1. Analysis of Cough Recording Completeness 
The duration of recording time (hours) within each patient’s cough recording will be summarized using 
descriptive statistics at each visit by treatment for the FAS.  As well, the number and percentage of 
patients with a duration of recording time that is >=20 hours, >=22 hours, >=23 hours, and 24 hours will 
be summarized at each treatment by visit for the FAS. 
9. Safety Analysis 
 
All summaries of safety will be performed on the safety population. 
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9.1. Adverse Events 
 
Treatment Emergent Adverse Events (TEAEs) will be defined as an adverse event that may have an 
onset following administration of study drug.  For the purposes of classifying adverse events according to 
this definition, events with partial onset dates will be considered as the closest possible date to the last 
day of study drug dosing.  In general, summaries will be provided by treatment group, and by MedDRA 
system organ class (SOC) and preferred term (PT). 
9.1.1. Incidence of Adverse Events 
An overall summary of TEAEs will be presented by treatment group and will include the number and 
percentage of patients with at least one TEAE, any serious TEAEs, any fatal TEAEs, and any TEAEs 
leading to discontinuation of study drug.  The 95% confidence intervals for these percentages by the 
Clopper-Pearson method will be presented.  Similarly, the number of patients experiencing these events 
will be compared at each level of active S-600918 dosing to placebo using Fisher’s exact test. 
 
The number and percentage of patients with TEAEs will be summarized by SOC and PT for each 
treatment.  All AEs will be presented in a listing. 
9.1.2. Relationship of Adverse Events to Study Drug 
An overall summary of treatment-related TEAEs will be presented by treatment group and will include the 
number and percentage of patients with at least one treatment-related TEAE, any serious treatment-
related TEAEs, any fatal treatment-related TEAEs, and any treatment-related TEAEs leading to 
discontinuation of study drug.  The 95% confidence intervals for these percentages by the Clopper-
Pearson method will be presented. 
 
The number and percentage of patients with treatment-related TEAEs will be summarized by SOC and 
PT for each treatment. 
9.1.3. Severity of Adverse Event 
The number and percentage of patients with TEAEs by severity will be presented by MedDRA system 
organ class and preferred term for each treatment group.  Each patient will be counted only once within a 
preferred term or system organ class at the most extreme observed level of severity. 
9.1.4. Serious Adverse Events 
The number and percentage of patients with serious TEAEs at any time will be summarized by SOC and 
PT for each treatment.  All serious TEAEs will be presented in a separate listing. 
9.1.5. Adverse Events Leading to Treatment Discontinuation 
The number and percentage of patients with TEAEs leading to discontinuation of study drug will be 
summarized by SOC and PT for each treatment.  All TEAEs leading to discontinuation of study drug will 
be presented in a separate listing. 
9.1.6. Death 
All TEAEs with an outcome of death will be presented in a separate listing. 
9.1.7. Subgroup Analyses for Adverse Events 
The number and percentage of patients with TEAEs will be similarly summarized for each treatment by 
Region (United States, Europe, Japan). 
 
Forest plots of the relative risk and its 95% confidence interval of TEAEs between each active treatment 
group and placebo will be presented for the subgroups above for TEAEs. 
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9.1.8. Taste Changes 
The number and percentage of patients with any treatment-emergent adverse events that reflect taste 
change as defined using the Standardized MedDRA Query (SMQ) category of “Taste and smell 
disorders” will be summarized by SOC and PT for each treatment group.   
 
As well, the number and percentage of patients with any treatment-emergent adverse events shown in 
Table 9-1 will be summarized by SOC and PT for each treatment group.   
 
Table 9-1: Adverse Events Reflecting Taste Change 
 
Preferred 
Terms Code 
System Organ 
Class Code 
Preferred Terms Name 
System Organ Class Name 
10001480 
10029205 
Ageusia 
Nervous system disorders 
10013911 
10029205 
Dysgeusia 
Nervous system disorders 
10019071 
10037175 
Hallucination, gustatory 
Psychiatric disorders 
10020989 
10029205 
Hypogeusia 
Nervous system disorders 
10064480 
10022891 
Gustometry abnormal 
Investigations 
10069147 
10029205 
Hypergeusia 
Nervous system disorders 
10082490 
10029205 
Taste disorder 
Nervous system disorders 
 
Responses to the taste questionnaire will be summarized descriptively and listed. 
 
 
 
 
 
 
9.2. Clinical Laboratory Evaluations 
 
Clinical laboratory samples will be analyzed using a central laboratory, and results will be provided in SI 
and US units with the appropriate normal ranges.  All laboratory results will be listed. 
 
The results from the samples collected at Visit 2, Visit 4, Visit 6, and Visit 7 will be summarized using at 
each visit.  For continuous results, both the results and change from baseline of the results will be 
summarized.  Continuous chemistry, hematology, and urinalysis results will be summarized using SI units 
and US units. 
 
Chemistry results except for blood urea nitrogen and total protein and hematology results except for 
hematocrit, erythrocytes (red blood cells), basophil count, and monocyte count will be categorized 
according to CTCAE version 5 and listed.  Cross tables of these grades at Visit 2 and each of Visit 4, Visit 
6 and Visit 7 will be prepared by each parameter.  For the cross tables, grades will be summarized using 
SI units for patients enrolled at sites outside the United States and using US units for patients enrolled at 
sites within the United States. 
 
Qualitative results for urinalysis will be summarized by the number and percentage of patients with results 
in each category by treatment group at each visit. 
 
Significant abnormalities will be defined for ALT, AST, and Total Bilirubin.  An AST or ALT result >3 x 
ULN and a total bilirubin value >2 x ULN will be considered an abnormality.  The number and percentage 
of patients experiencing either and both of these abnormalities after the first dose of study drug up 
through the follow-up visit will be summarized by treatment group.  As well, the number and percentage of 
patients experiencing an AST results >3 x ULN, an ALT results >3 x ULN, an AST or ALT results >5 x 
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ULN, prothrombin time international normalized ratio (PT-INR) >1.5, and (an AST or ALT result >3 x ULN) 
and (a total bilirubin value >2 x ULN or PT-INR >1.5) will be summarized.  A separate listing will present 
all ALT, AST, and total bilirubin results for any patients with either abnormality. 
 
Numbers of patients and their proportions whose creatinine increased more than 0.3 mg/dL for patients 
enrolled in the United States or more than 26 umol/L for patients enrolled outside of the United States 
from Visit 2 at each of Visits 4, 6, 7 and any time point during treatment period and follow-up period will 
be summarized.  A separate listing will present all creatinine results for any patients with an increase 
greater than 0.3 mg/dL from Visit 2. 
9.3. Vital Sign Measurements 
 
Blood pressure and pulse rate will be recorded at each visit in the study.  Observations at Visit 3, Visit 4, 
Visit 5, Visit 6, and Visit 7 will be summarized using descriptive statistics.  The change from baseline will 
also be summarized for these Visit 4, Visit 5, Visit 6, and Visit 7, with baseline defined as the last 
observation prior to the first administration of study drug.  All vital signs data will be listed. 
9.4. Physical Examination 
 
A physical examination will be performed at each visit, except for Visit 5.  All physical examinations after 
Visit 1 will be abbreviated and limited to the respiratory system only.  All physical exam data will be listed. 
9.5. Electrocardiogram 
 
Qualitative assessments of electrocardiograms (ECG) conducted at Visit 1, Visit 2, Visit 6, and Visit 7 will 
be summarized by treatment group and by visit according to the number and percentage of patients 
reporting an ECG result in each result category.  These assessments will be reported as normal, 
abnormal-not clinically significant, or abnormal-clinically significant. 
10. Pharmacokinetics 
 
All presentations of data related to pharmacokinetics will be presented for the PK Concentration 
Population. 
 
Individual plasma concentrations of S-600918 and its metabolite S-600918 acyl glucuronide will be listed 
with the actual time elapsed from administration of the last dose by patient and plotted against the actual 
time elapsed from the last dose. In addition, plasma concentrations of S-600918 and S-600918 acyl 
glucuronide within 20 to 28 hours after the last dose will be summarized as plasma trough concentrations 
(Ctrough) by dose and scheduled visit (Visit 4 and Visit 6) with N, Mean, SD, and coefficient of variation 
(CV%, calculated by SD/Mean × 100); geometric mean (Geometric Mean) and coefficient of variation for 
geometric mean (CV% Geometric Mean); and median, minimum (Min) and maximum (Max) values. The 
CV% Geometric Mean will be calculated according to the following formula: CV% Geometric Mean = [exp 
(sd2) − 1]1/2 × 100, where sd is the standard deviation for natural log (ln) - transformed data.  
 
The relationships between Ctrough and dose will be presented graphically by scheduled visit (Visit 4 and 
Visit 6) for S-600918 and for S-600918 acyl glucuronide.  If Ctrough is below the lower limit of quantitation, 
Mean, SD, CV%, Min, Median, and Max will be calculated as 0, and that value will not be included in the 
calculation of Geometric Mean and CV% Geometric Mean. 
 
Plasma drug and metabolite concentrations determined in blood samples obtained outside of allowable 
time windows will be included in PK analyses and will not be handled as missing data. 
Individual plasma concentrations, if deemed to be anomalous, may be excluded from the analysis at the 
discretion of the PK analyst. Any such exclusion will be communicated to the sponsor and clearly 
represented in the study report along with justification for exclusion. 
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Descriptive statistics for Ctrough will be presented as follows:  
• 
N: no decimal place 
• 
Mean, Geometric Mean, SD, median, Min, and Max: same precision as per the observed values. 
• 
CV% and CV% Geometric Mean: one decimal place 
11. Pharmacodynamics 
 
There are no pharmacodynamic analyses planned for this study. 
12. Interim Analysis 
 
No Interim analysis is planned for this study. 
13. Changes in the Planned Analysis 
 
There are no changes in the planned analyses described in the protocol within this SAP. 
 
 
 
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14. Appendices 
14.1. 
Appendix 1: Schedule of Study Procedures 
 
 
 
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14.2. 
Appendix 2: Handling of Cough Counts 
 
The number of coughs per hour is used in the following situations in the efficacy analyses: 
• 
in 24 hours 
• 
while awake 
• 
while asleep 
 
The number is commonly derived by the formula given below: 
 
𝑁𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑐𝑜𝑢𝑔ℎ𝑠 𝑝𝑒𝑟 ℎ𝑜𝑢𝑟= 𝑇𝑜𝑡𝑎𝑙 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑐𝑜𝑢𝑔ℎ𝑠 𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑑 𝑖𝑛 𝑒𝑣𝑎𝑙𝑢𝑎𝑡𝑖𝑜𝑛 𝑠𝑒𝑠𝑠𝑖𝑜𝑛
𝑇𝑜𝑡𝑎𝑙 𝑙𝑒𝑛𝑔𝑡ℎ 𝑜𝑓 𝑒𝑣𝑎𝑙𝑢𝑎𝑡𝑖𝑜𝑛 𝑠𝑒𝑠𝑠𝑖𝑜𝑛 𝑖𝑛 ℎ𝑜𝑢𝑟𝑠
 
 
 
Each evaluation session is, at most, 24 hours.  The above formula applies even when the total length of 
evaluation is less than 24 hours.  There is no minimum length required to apply the formula above.  MILLI 
in Events dataset stands for millisecond in the event time, and it is handled in the formula above, too.  
MILLI is always missing when FACAT is “SESSION”, corresponding to start date and time of session and 
expected end date and time of session, respectively.  MILLI whose FACAT is “SESSION” will be imputed 
with 0 when MILLI in the last record in the current session is missing, otherwise with the same value of 
MILLI in the last record in the current session, respectively.  Any counts of coughs after 24 hours since 
cough monitoring has started will not be considered for evaluation.  The evaluation session starts while 
patient is awake. The evaluation session is curtailed to last observable time of the measured data if there 
is no record after 24 hours since cough monitoring has started. 
 
The above termination of session has exception in the following three cases 1) Termination for some 
reason including due to battery exhaustion in monitoring device or artificial termination (FAOBJ=”Early 
Termination”), 2) Intermittent removal (where FAOBJ=”Removal”) without any records with FAOBJ to be 
either of “Restore”, “Cough”, “Sleep” or “Wake” after the appearance of record.  The time in these records 
is regarded as the end of the evaluation session. 
 
The evaluation session excludes interruptions as below 
 
1) between removal time (FAOBJ=”Removal”) and its restoration time (FAOBJ=”Restore”) by device 
removal. 
2) between flagged area started (FAOBJ=”Flagged Area Start”) to its end (FAOBJ=”Flagged Area End”) 
in case of unintentional missing count due to noise. 
3) between mute started (FAOBJ=”Mute Start”) to its end (FAOBJ=”Mute End”) during pressing Mute 
button by subject. 
 
The number of coughs in such interrupted sessions will not be used even if recorded due to its 
unreliability. 
 
If either counting is rejected or device is unassigned, then the number of coughs is considered as 
missing. If under 1 hour of data exists, it will not be analyzed by Vitalograph, and it will be rejected on the 
portal provided by Vitalograph, as per “Cough Analysis Plan: S2019323_0001, Project No. S2019323” 
prepared by Vitalograph. Otherwise if there is no record of cough, then the number of coughs is set to be 
0. 
 
The length of awake of 20 minutes or less will not be handled as awake session, as such a record will not 
be included in the database. 
 
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When any of the number of coughs per hour in 24 hours at baseline or during treatment period is 0, 0.1 
will be added to all of the number of coughs per hour in 24 hours in order to apply the mixed effect model. 
Likewise, this handling is applied to those while awake and asleep, too. 
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