Clinical trial NCT04794491
Conditions: Narcolepsy
Sponsor: Jazz Pharmaceuticals
Start date: 2021-03-22; Completion date: 2022-11-15
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.

Detailed description:

Arms: arm 1: Conversion from Xyrem to XYWAV, maintaining the dose and regimen of any concomitant anticataplectics or stimulants unchanged throughout study.
Interventions: intervention 1: JZP-258
Intervention descriptions: intervention 1: Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose \> 6 g

Protocol documents:
Prot_000.pdf: 
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08 Dec 2020
CONFIDENTIAL
Page 4 of 66
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08 Dec 2020
CONFIDENTIAL
Page 5 of 66
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08 Dec 2020
CONFIDENTIAL
Page 6 of 66
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Page 15 of 66
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CCI

SAP_001.pdf: 
Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
1
STATISTICAL ANALYSIS PLAN
VERSION: 1.1
DATE: 12-DEC-2022
PROTOCOL/STUDY NUMBER:
JZP258-401-00
Protocol Amendment: N/A (Original)
STUDY TITLE:
A Phase 4 Multicenter, Open-label, Single-arm Study of Safety, Tolerability, Effectiveness and 
Treatment Optimization in Participants Switching From Xyrem to XYWAV for the Treatment of 
Narcolepsy
SPONSOR:
Jazz Pharmaceuticals
3170 Porter Dr, Palo Alto, CA 94304
Confidentiality Statement
The information in this document is Jazz Pharmaceuticals confidential information. This material may be used 
only for evaluating or conducting clinical investigations; any other proposed use requires written consent from 
Jazz Pharmaceuticals. Acceptance of this document constitutes an agreement by the recipient(s) that no 
unpublished information contained herein will be published or disclosed without first obtaining written approval 
from Jazz Pharmaceuticals. This document may be disclosed to appropriate Investigational Review Boards/Ethics 
Committees under the condition of confidentiality.
This study is being conducted in compliance with Good Clinical Practice (GCP) guidelines.


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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
2
SIGNATURE PAGE
This document has been prepared by:
Senior Principal Statistician
Jazz Pharmaceuticals
Date
Senior Principal Statistician
Jazz Pharmaceuticals
Date
This document has been reviewed and approved by:
Senior Director, Biostatistics
Jazz Pharmaceuticals
Date
Director, Clinical Scientist Lead
Jazz Pharmaceuticals
Date
Director, Global Medical Affairs
Jazz Pharmaceuticals
Date
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
3 
TABLE OF CONTENTS
TABLE OF CONTENTS.................................................................................................................3 
LIST OF TABLES...........................................................................................................................5 
LIST OF FIGURES .........................................................................................................................5 
1. 
LIST OF ABBREVIATIONS.......................................................................................6 
2. 
MODIFICATION HISTORY.......................................................................................8 
3. 
INTRODUCTION........................................................................................................9 
4. 
STUDY OBJECTIVES AND ENDPOINTS................................................................9 
4.1. 
Study Objectives...........................................................................................................9 
4.1.1. 
Objective.......................................................................................................................9 
4.1.2. 
Exploratory Objective...................................................................................................9 
4.2. 
Study Endpoints............................................................................................................9 
4.2.1. 
Key Endpoints ..............................................................................................................9 
4.2.2. 
Exploratory Endpoints..................................................................................................9 
5. 
STUDY DESIGN .......................................................................................................10 
5.1. 
Summary of Study Design..........................................................................................10 
5.2. 
Study Treatment..........................................................................................................10 
5.3. 
Power and Sample Size Considerations .....................................................................11 
5.4. 
Randomization and Blinding......................................................................................12 
5.5. 
Interim Analysis..........................................................................................................12 
6. 
ANALYSIS SETS ......................................................................................................12 
7. 
GENERAL ASPECTS FOR STATISTICAL ANALYSIS........................................13 
7.1. 
General Methods.........................................................................................................13 
7.2. 
Baseline and Study Day Definitions...........................................................................13 
7.2.1. 
Baseline.......................................................................................................................13 
7.2.2. 
Study Day ...................................................................................................................14 
7.2.3. 
Visit Windows ............................................................................................................14 
7.2.4. 
Missing and Partial Data.............................................................................................15 
7.3. 
Hypotheses Testing.....................................................................................................15 
7.4. 
Level of Significance & Multiplicity Adjustment......................................................15 
7.5. 
Subgroups and Subgroup Analyses ............................................................................16 
7.6. 
Changes to Planned Analyses.....................................................................................16 
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
4 
8. 
STUDY POPULATION SUMMARIES ....................................................................16 
8.1. 
Enrollment ..................................................................................................................16 
8.2. 
Subject Disposition.....................................................................................................16 
8.3. 
Demographic and Baseline Characteristics ................................................................16 
8.4. 
Medical/Surgical History............................................................................................17 
8.5. 
Prior and Concomitant Medications ...........................................................................17 
8.6. 
Protocol Deviations ....................................................................................................17 
9. 
EFFECTIVENESS .....................................................................................................18 
9.1. 
Key Effectiveness Endpoints and Analysis ................................................................18 
9.1.1. 
Rate of Cataplexy Attacks ..........................................................................................18 
9.1.2. 
Epworth Sleepiness Scale (ESS) ................................................................................18 
9.1.3. 
Participant Global Impression of Change (PGIc).......................................................19 
9.1.4. 
Dose and Regimen Changes in Intervention Period...................................................19 
9.1.5. 
Characterization of Meals Relative to Dosing............................................................19 
9.1.6. 
Sensitivity Analyses....................................................................................................19 
9.1.7. 
Subgroup Analyses .....................................................................................................20 
9.2. 
Exploratory Endpoints................................................................................................20 
9.2.1. 
Ease of Switching Medication Scale (EOSMS) .........................................................20 
9.2.2. 
Forced Preference Questionnaire (FPQ).....................................................................20 
10. 
SAFETY AND TOLERABILITY..............................................................................20 
10.1. 
Exposure .....................................................................................................................20 
10.1.1. 
Extent of Exposure .....................................................................................................20 
10.1.2. 
Treatment Compliance................................................................................................20 
10.2. 
Adverse Events ...........................................................................................................21 
10.3. 
Physical Examinations................................................................................................23 
10.4. 
Clinical Laboratory Assessment.................................................................................23 
10.5. 
Pregnancy Testing ......................................................................................................24 
10.6. 
Vital Signs ..................................................................................................................24 
10.7. 
Electrocardiograms.....................................................................................................25 
10.8. 
Nausea Visual Analog Scale.......................................................................................25 
10.9. 
Suicidal Ideation and Behavior Risk Monitoring.......................................................26 
10.10. 
Participant Health Questionnaire-9.............................................................................26 
11. 
PHARMACOKINETIC ANALYSES........................................................................26 
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
5 
12. 
PHARMACODYNAMIC ANALYSES.....................................................................26 
APPENDICIES..............................................................................................................................27 
Appendix 1.1: Adverse Event Date Imputation Rules................................................................27 
Appendix 1.2: Prior/Concomitant Medications Date Imputation Rules .....................................29 
Appendix 2: Listing of Anticataplectics and Stimulants.............................................................30 
LIST OF TABLES 
Table 1 
Analysis Set ................................................................................................................12 
Table 2  
Total Daily Volume of Solution (mL)........................................................................21 
Table 3  
List of Laboratory Tests..............................................................................................23 
Table 4  
Vital Signs Predefined Markedly Abnormal Criteria .................................................25 
LIST OF FIGURES
Figure 1 
Overall Design of Study JZP258-401.........................................................................11 
 
 
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
6 
1.
LIST OF ABBREVIATIONS
Abbreviation
Term
AE
adverse event
ALB
albumin
ALK-P
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
BP
blood pressure
bpm
beats per minutes
BUN
blood urea nitrogen
Ca
Calcium
CBC
complete blood count
CFR
Code of Federal Regulations
CI
confidence interval
Cl
Chloride
CRF
case report form
COVID-19
coronavirus disease 2019
C-SSRS
Columbia Suicide Severity Rating Scale
CSR
clinical study report
CTCAE
common terminology criteria for adverse events
CTMS
clinical trial management system
DBP
diastolic blood pressure
DSM-5
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
E/D
early discontinuation
ECG
electrocardiogram
eCRF
electronic case report form
EDS
excessive daytime sleepiness
EOSMS
Ease of Switching Medications Scale
ESS
Epworth Sleepiness Scale
ET
end of treatment
EU
European Union
FDA
Food and Drug Administration
FPQ
Forced Preference Questionnaire
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
7 
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
HCG
human chorionic gonadotropin
HR
heart rate
ICF
informed consent form
ICH
International Council for Harmonisation
IRT
interactive response technology
K
Potassium
MedDRA
Medical Dictionary for Regulatory Activities
Na
Sodium
NCI
National Cancer Institute
NT1
Narcolepsy Type 1
NVAS
Nausea Visual Analog Scale
PE
physical examination
PGIc
Participant Global Impression of Change
PHQ-9
Participant Health Questionnaire-9
PK
Pharmacokinetic
PR
pulse rate
PT
preferred term
SAE
serious adverse event
SAP
statistical analysis plan
SBP
systolic blood pressure
SD
standard deviation
SE
standard error
SoA
Schedule of Activities
SOC
System Organ Class
TEAE
treatment-emergent adverse event
TSH
thyroid stimulating hormone
US
United States
WBC
white blood cell count
WHO
World Health Organization
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
8 
2.
MODIFICATION HISTORY
Version History for SAP:
Version
Date
Description 
V1.0
09 NOV 2022
Original SAP
V1.1
12 DEC 2022
Removed references to ATC coding,
updated MedDRA and WHODRUG 
database versions.
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Statistical Analysis Plan – Protocol JZP258-401-00
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3.
INTRODUCTION
The purpose of this statistical analysis plan (SAP) is to describe in detail the statistical 
methodology and planned analyses to be conducted for Protocol JZP 258-401-00, “A Phase 4 
Multicenter, Open-label, Single-arm Study of Safety, Tolerability, Effectiveness and Treatment 
Optimization in Participants Switching from Xyrem to XYWAV for the Treatment of 
Narcolepsy” for inclusion in the Clinical Study Report (CSR). The current version is based on 
Original Protocol dated 08Dec2020. Any additional analyses or deviation from the analyses 
outlined in this plan will be documented with rationale in the interim and/or final CSR.
4.
STUDY OBJECTIVES AND ENDPOINTS
4.1.
Study Objectives
4.1.1.
Objective
The objective of this study is to describe the clinical experience of participants switching from 
Xyrem to XYWAV for the treatment of narcolepsy with or without cataplexy in terms of safety, 
tolerability, effectiveness, and treatment optimization.
4.1.2.
Exploratory Objective 
The exploratory objective of this study is to describe the ease of conversion and participant 
preference of XYWAV in participants with narcolepsy with or without cataplexy.
4.2.
Study Endpoints
4.2.1.
Key Endpoints
x
Adverse Events and Serious Adverse Events
x
Change in the Nausea Visual Analog Scale
x
Change in weekly rate of cataplexy attacks (for Narcolepsy Type 1)
x
Change in Epworth Sleepiness Scale to assess excessive daytime sleepiness
x
Participant Global Impression of Change
x
Time to optimized dose and regimen
x
Number of changes from first dose and regimen to optimized dose and regimen
x
Number of participants dosing fasted versus dosing without consideration of food
x
Timing and characterization of meals relative to dosing
4.2.2.
Exploratory Endpoints
x
Ease of Switching Medications Scale
x
Forced Preference Questionnaire
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5.
STUDY DESIGN
5.1.
Summary of Study Design
Study JZP258-401 is an open-label, single-arm, interventional study that is intended to provide 
descriptive assessments of safety, tolerability, effectiveness and optimization of treatment during 
participant transition from Xyrem to XYWAV. The dosing information obtained in this trial may 
be used to support that XYWAV can be dosed with or without food. If warranted, the data 
obtained from this study would be included to support future label discussions with regulatory 
agencies. 
The target study population is participants with narcolepsy, with or without cataplexy that have 
remained on a stable regimen of Xyrem for no less than 2 months prior to start of this study, at 
any prescribed dose (up to a maximum of 9 grams) taken once, twice, or thrice nightly and with 
no single dose exceeding 6 grams. 
5.2.
Study Treatment
All participants will continue to stay on stable Xyrem dose and regimen during screening and 
baseline periods.  During the Open Label Conversion and Treatment Optimization period, 
participants will switch to XYWAV initially at the same dose (gram-per-gram) and regimen as 
Xyrem, then expand the dose and regimen upon optimization with or without food.  The total 
duration of the study is expected to be approximately 17 months, with duration of individual 
participant participation around 3 to 3.5 months. The study (Figure 1) comprises the following 
phases:
Screening Period (Up to 30 days) 
To be eligible for the study, all participants must have been titrated to a tolerable and effective 
dose and regimen of Xyrem (with or without concomitant anticataplectics or stimulants), which 
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period of up to 30 days, all participants will be evaluated for eligibility based on screening 
assessments, with the option to be rescreened once if the rescreening is approved by the Medical 
Monitor. Rescreening may occur following resolution of transient exclusionary conditions or 
stabilization of conditions that were exclusionary in the unstable state (eg, unstable 
hypothyroidism) and is permitted only with the permission of the Medical Monitor. Participants 
who are approved for rescreening must be re-consented if re-screening occurs more than 28 days 
after the first consent, in which case, a new participant identification number should be assigned,
and all screening procedures should be repeated.
Baseline Period (2 weeks) 
Following study entry, participants will remain on the same stable dose and regimen of Xyrem 
during a 2-week Baseline period. Baseline weekly rates of cataplectic attacks and ESS scores (as 
a measure of EDS) will be determined in this period, in addition to other baseline treatment and 
safety measures as outlined in Schedule of Activities (Protocol JZP258-401-00 Section 1.3). 
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Intervention (Open-Label Conversion and Treatment Optimization) Period (6 weeks) 
During the Intervention (Open-Label Conversion and Treatment Optimization) period, 
participants on a stable dose and regimen of Xyrem will be switched to the same dose (gram-per-
gram) and regimen of the study intervention drug (XYWAV). Any concomitant anticataplectics 
or stimulants will be maintained as per their current dose and regimen throughout the study. 
Once the investigator determines that a stable dose and regimen has been achieved, XYWAV 
may be taken with or without food. If needed, XYWAV may be titrated to an optimized dose and 
regimen based on efficacy and tolerability, under the advisement and instruction from the 
investigator, with the goal to end the period with  2 weeks of optimized therapy on XYWAV. 
Safety Follow-up Period 
Following the Intervention period, participants will return for a Safety Follow-up visit 2 weeks 
after the End of Treatment (ET) or Early Discontinuation (E/D). Following the ET or E/D, 
including during the Safety Follow-up period, it is understood and expected that investigators 
will determine the appropriate course of care with the participant, and may resume any 
prescribed medications that were discontinued prior or during the study. There is no plan to 
monitor participants beyond the 2-week Safety Follow-up period. 
Figure 1
Overall Design of Study JZP258-401
*Adjustment to achieve optimal clinical benefit, with adequate control of cataplexy and EDS while maintaining tolerability per 
investigator judgment. 
Abbreviation: EDS = excessive daytime sleepiness; wks = weeks
5.3.
Power and Sample Size Considerations
An estimated total of 100 participants will be enrolled into this single-arm study. This number is 
considered sufficient to meet the study objectives. A formal sample size calculation has not been 
performed and formal hypothesis testing is not planned for data in this study.
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5.4.
Randomization and Blinding
All participants who sign the informed consent form (ICF) will receive a participant number. The 
participant number identifies the participant for all study procedures that occur throughout the 
study. This number is unique and once assigned, cannot be reassigned to another study 
participant. Study JZP258-401 is an open-label, single-arm trial, and therefore will have no 
blinding. Treatment allocation for this study will occur centrally through the use of an interactive 
response technology (IRT).
5.5.
Interim Analysis
Based on enrollment, an optional interim analysis may be conducted after approximately the first 
25 participants and 50 participants respectively, have completed or prematurely terminated the 
study to provide an early understanding of the clinical experience of participants switching from 
Xyrem to XYWAV. This data may be presented externally. This process will occur with no 
pause in enrollment. 
As formal hypothesis testing is not performed, no alpha adjustments will be made for any interim 
analyses. 
A Data Monitoring Committee will not be used for this study.
6.
ANALYSIS SETS
For purposes of analysis, the following populations are defined:
Table 1
Analysis Set
Analysis Set
Description
All Screened 
The All Screened Analysis Set will include all subjects who 
provided a signed informed consent for this study. 
This analysis set will be used to summarize the number of 
screened, screen failure and enrolled subjects.
Enrolled 
All participants who sign the informed consent form and meeting 
all eligibility criteria for the study.
This analysis set will be used to summarize participant disposition, 
major protocol deviations (as classified in CTMS), and 
inclusion/exclusion from the Safety Analysis Set, including 
reasons for exclusion from it. 
Safety
The Safety Analysis Set will include all participants in the 
Enrolled Analysis set who take at least one dose of Xyrem after 
providing informed consent. 
This analysis set will be used for summaries of all endpoints,
except those which only pertain to data captured during the 
Intervention Period.
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Analysis Set
Description
XYWAV Safety
The XYWAV Safety Analysis Set will include all participants in 
the Safety Analysis Set who take at least one dose of XYWAV. 
This analysis set will be used for summaries of all endpoints which 
pertain to only data captured during the Intervention Period.
XYWAV Efficacy
The XYWAV Efficacy Analysis Set will include all participants in 
the XYWAV Safety Analysis Set who finish the course of study.
This analysis set will be used for summaries of all endpoints which 
pertain to only data captured during the Intervention Period.
7.
GENERAL ASPECTS FOR STATISTICAL ANALYSIS
The statistical principles applied in the design and planned analyses of this study are consistent 
with International Conference on Harmonization (ICH) E9 guidelines (ICH 1998).
7.1.
General Methods
Assessments of all study endpoints (as listed in Section 4.2 will be summarized descriptively. 
Formal hypothesis testing will not be performed. 
In general, categorical variables will be reported as frequency and percent. Continuous variables 
will be reported as the number of participants, mean, standard deviation (SD), or standard error 
(SE), median, minimum and maximum or range.
For quantitative measures, change from baseline will be calculated as:
Change from baseline = test value at Visit X – test value at baseline
All data will be summarized in tables with a single “overall” column for statistics. As applicable, 
data will be summarized by visit and/or study period.
All summaries, statistical analyses, and individual participant data listings described below will 
be completed using Version 9.4 or later of the SAS Statistical Analysis System (SAS Institute, 
Inc. Cary, NC).
7.2.
Baseline and Study Day Definitions
7.2.1.
Baseline
For all safety assessments and effectiveness summaries across the study, study baseline will be 
defined as the last non-missing measurement collected/ assessed during the Baseline (Xyrem) 
Period in which participants remain on a stable Xyrem dose and regimen, with or without 
concomitant anticataplectics or stimulants. First dose of XYWAV will be administered in the 
first night of Visit 3. Assessment and data collected in the baseline period up till that night, will 
be included in this period.
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7.2.2.
Study Day
The screening period is from Day -30 to Day -1.  The 2-week baseline period is Day 1 to Day 14.
Participants on a stable dose and regimen of Xyrem will be switched to XYWAV treatment at 
the beginning of the Intervention (Open-label Conversion and Treatment Optimization) period, 
starting the night of Visit 3/Day 15 and continue through to the End of Treatment (ET) (Visit 8) 
or Early Discontinuation (E/D) visit, as applicable. 
Study day will be calculated as:
Study Day = (the date of assessment or event - the first day of the baseline period (Visit 2)) + 1
XYWAV Study Day = (date of assessment - date of first dose of XYWAV) + 1
7.2.3.
Visit Windows
Except where specified, all data will be summarized using the CRF visit at which the data was 
collected. Where data is captured at an Early Termination visit, those data will be summarized 
with the regular visit at which the assessment would have been captured, relative to the study 
period during which the participant withdrew. For example: 
x
If a participant early discontinues during the Baseline Period, i.e. prior to the first dose of 
XYWAV, then data should be mapped to Visit 3.
x
If a participant early discontinues during the Intervention Period, i.e. after at least one 
dose of XYWAV, then data should be mapped to the next scheduled visit at which those 
data would have been captured, based on the Schedule of Assessments.
For data captured independent of a CRF visit, eg, Adverse Events, Concomitant Medications and 
Cataplexy Diary, the following rules will apply:
x
If the reported date is on or prior to first dose of XYWAV then the data will be 
considered to be included into the Xyrem Baseline Period for summaries
x
If the reported date is after the first dose of XYWAV while on or prior to the completion
of treatment or early discontinuation, then the data will be considered to be included into
the XYWAV Intervention Period for summaries. 
Unscheduled visits in general will not be mapped (excluded from analyses) when the 
corresponding scheduled visit is present. Unscheduled visits will only be mapped when the
scheduled visit is missing. If more than 1 unscheduled assessments are available, choose the one 
with the assessment date closer to the target study day specified below, if 2 assessments are 
equally close to the target day (but on different sides), the latter assessment will be chosen. In 
addition, unscheduled visits with the assessment date earlier than the date of first dose of 
XYWAV, or participants early discontinue the study prior to the first dose of XYWAV, the data
can only be mapped up to Visit 3. If the assessment date is later than the date of first dose of 
XYWAV, the unscheduled data should not be mapped to any visit prior to Visit 3. 
Study Period 
Study Visit
Target Study Day
Baseline
Visit 2
1
Intervention
Visit 3 
15
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Intervention
Visit 4
22
Intervention
Visit 5
29
Intervention
Visit 6
36
Intervention
Visit 7
43
Intervention
Visit 8
57
Where summaries require a period of time, eg, the last week of a study period, this will be 
determined based on the actual visit date, as long as the above rule is maintained. For example, if 
a participant has a first dose of XYWAV on Day 15 and Early Terminates on Day 20, the last 
week of XYWAV will be only Days 16-20, as the participant received Xyrem on Days 14 and 15 
(the first dose of XYWAV being taken the night of Day 15). Imputation due to the missing data 
this approach generates will follow rules outlined in Section 7.2.4.
7.2.4.
Missing and Partial Data
Participants who drop out will not be replaced. All reported data will be included in the 
summaries without imputation of any missing data. Any missing data for diary data for cataplexy 
attacks and Nausea Visual Analog Scale (NVAS), or any missing item score for Epworth 
Sleepiness Scale (ESS) will be treated as follows:
x
For participants experiencing at least 1 day of non-missing cataplexy attack, the weekly 
number of cataplexy attacks will be derived as the average number of daily attacks from 
days with non-missing data within the week, multiplied by 7. Note: 1 or more daily 
entries in the cataplexy attack dairy are required to be completed for the weekly average 
cataplexy attack calculation. Otherwise, the weekly score is recorded as missing.
x
For participants with at least 1 day of NVAS data, the NVAS for that week will be the 
average daily score from days with non-missing data within the week, then multiplied by 
7.
x
For participants experiencing 3 or more ESS item scores missing at a specific timepoint, 
the ESS total score will be set to missing. If 1 or 2 ESS item scores are missing at a 
specific timepoint, the mean of remaining 7 or 6 non-missing ESS item scores at that 
timepoint will be used to impute the missing ESS item value. ESS total score will be 
calculated as the sum of the observed and imputed item scores. 
7.3.
Hypotheses Testing
All endpoints (listed in Section 4.2) will be summarized descriptively. Formal hypothesis testing 
will not be performed.
7.4.
Level of Significance & Multiplicity Adjustment
As this study does not test a formal hypothesis, there is no multiplicity adjustment. For specific
statistics, for example, difference in proportions, 95% CI based on normal approximation will be 
generated.
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7.5.
Subgroups and Subgroup Analyses
Subgroup analyses will be performed when applicable. See Section 9.1.7.
7.6.
Changes to Planned Analyses
The changes in planned analyses between the protocol and SAP are the following:
x
All Screened Analysis Set, XYWAV Safety Analysis Set and XYWAV Efficacy 
Analysis set are added in addition to the analysis sets defined in protocol section 9.3.
Exclude potential screen failures from Enrolled Analysis Set defined in protocol section 
9.3.
x
National Cancer Institute (NCI) common terminology criteria for adverse events 
(CTCAE) version 5.0 or higher is added as the reference for AE severity classification.
8.
STUDY POPULATION SUMMARIES
8.1.
Enrollment
The total number and percentage of participants for each Analysis Set defined in Section 6 will 
be summarized. The number of participants who enrolled by country and study site/Investigator 
will be summarized.
8.2.
Subject Disposition
All participants who provide informed consent will be accounted for in this study. For each 
period, the number and percentages of participants who entered, received at least one dose, 
completed, are still ongoing (for interim analyses), and early discontinuation, including reasons 
for discontinuation, will be presented using the enrolled analysis set.
Note that coronavirus disease 2019 (COVID-19) impacts throughout the study will be captured
at each non-remote visit for the type of visit performed due to COVID-19 and study related 
impacts due to COVID-19. These will be summarized by visit based on enrolled analysis set.
8.3.
Demographic and Baseline Characteristics
Demographic and other baseline characteristics data will be summarized using descriptive 
statistics for the safety analysis set.
Demographic and other baseline characteristics include:
x
The age entered by the sites will be used. If it is missing, then it will be derived from 
date of birth and informed consent date. (For countries where regulations allow only 
the year of birth to be entered for birth date, July 1st of that year will be used for the 
calculation of age).
x
Gender
x
Race - participants who reported more than one race will be reported under ‘multiple’ 
race category
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x
Ethnicity
x
Childbearing potential
x
Baseline weekly cataplexy attack rate
x
Baseline ESS score
8.4.
Medical/Surgical History
Surgical and medical history will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA) dictionary, version 24.0, and are defined as those medical conditions/ 
diseases which started prior to or on the date of initial ICF signing.
Medical/surgical history data will be summarized by system organ class (SOC) and preferred 
term (PT) for the safety analysis set. If a participant reports a past medical condition/disease, 
surgery or past medication more than once within a SOC or PT, the medical condition/disease, 
surgery or past medication will be reported only once for that SOC or PT.
8.5.
Prior and Concomitant Medications
Medications will be coded to the preferred drug name using the World Health Organization 
(WHO) drug dictionary, version GLOBALB3Mar21, and will be classified as follows:
x
Prior medications are defined as any medications which started prior to the first dose of
XYWAV.
x
Concomitant medications will be defined as any medications with a stop date on or after 
the first conversion from Xyrem to XYWAV, during the study, or any medication that is 
ongoing. A medication with completely missing use dates or partially missing use dates 
without evidence that the medication was stopped prior to the first dose of study drug will 
be considered a concomitant medication.
Prior and Concomitant medications will be summarized by preferred drug name based on the 
safety analysis set. A listing will also be presented.
8.6.
Protocol Deviations
Protocol deviations as classified in the CTMS (type of deviation and severity) will be 
summarized across all study periods using enrolled analysis set.
Changes to study conduct due to COVID-19 restrictions will be reported as protocol deviations 
and summarized. All protocol deviations will also be provided in a listing. 
These COVID-19 related deviations will be summarized separately by the classification type in 
CTMS and included in a listing. 
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9.
EFFECTIVENESS
9.1.
Key Effectiveness Endpoints and Analysis
Unless otherwise specified, effectiveness data will be primary summarized using both the 
XYWAV Safety Analysis Set and XYWAV Efficacy Analysis Set.
9.1.1.
Rate of Cataplexy Attacks
Narcolepsy Type 1 (NT1) participants will be required to complete an electronic Cataplexy 
Frequency Diary daily. The weekly rate of cataplexy attacks is derived as the average number of 
daily attacks from days with non-missing data within the week multiplied by 7. The baseline 
value for cataplexy attack is the weekly rate of the last week of the baseline period on Xyrem.
For example, if the first dose of XYWAV is taken in the night of Day 16, the last week of 
baseline would be approximately Day 10 to Day 16, prior to the time of first dose of XYWAV.
After conversion, the weekly rate for each visit will be based on the days within the visit window 
as in Section 7.2.3.
Weekly rate for baseline and each visit will be summarized with number of participants, mean, 
SD, median, min and max. Changes in weekly cataplexy rate from the study baseline to that of 
each visit during the intervention period will be summarized with number of participants, mean, 
standard deviation, median, minimum, and maximum. Changes in weekly cataplexy rate from 
the XYWAV baseline to that of each visit after XYWAV conversion during the intervention 
period will be also summarized in a similar manner. Box-whisker plot weekly rate of cataplexy 
attack will be plotted over time.
Cataplexy attack rate will only be determined for NT1. If NT2 participants provide cataplexy 
attack diary data, those data will be listed but excluded from the summary of the endpoint.
9.1.2.
Epworth Sleepiness Scale (ESS)
The ESS measures EDS in 8 different situations with four choices of responses from 0 to 3. ESS 
total score ranges from 0 to 24.  
The ESS questionnaire will be completed by the participants at the baseline visit and at the End 
of Treatment (ET) visit.
ESS scores will be summarized for the baseline, ET, and the mean change from baseline at ET
for all participants. Summarized statistics will include number of participants, mean, standard 
deviation, median, minimum, and maximum. Mean (± SD) ESS scores will be plotted over time. 
A listing of all ESS data will be presented.
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9.1.3.
Participant Global Impression of Change (PGIc)
PGIc measures participant’s impression of improvement in the sleepiness from previous visit.
There are 7 categories ranging from very much improved to very much worse with 3 categories 
for improvement, 3 categories for no improvement, and one category for no change.
PGIc data will be collected at the end of the treatment period or at Early Discontinuation. A
summary statistics report will include the number of participants, tabulation of each of the 7 
categories and percent. The number and percent of participants reported improved and worsen 
will be generated.
9.1.4.
Dose and Regimen Changes in Intervention Period
Time to optimize dose and regimen is defined as the time (unit is day) from the first dose and 
regimen of XYWAV to the optimized dose and regimen of XYWAV, where the optimized dose 
and regimen is the final dose and regimen that remains unchanged throughout the remainder of 
the intervention period. Optimized dose and regimen is defined as follows:
x
The final dose and regimen that a participant takes before or at Visit 7 that remains 
unchanged to Visit 8 when the participant completes the XYWAV treatment, regardless 
of the time between Visits 7 and 8.
x
The final dose and regimen that remains the same for at least 2 weeks (14 days) for a 
participant who completes at least 21 days post conversion and then terminates the 
XYWAV treatment early. For example, a participant changes dose and/or regimen after 1
week (7 days) post conversion and terminates from the study at Day 38, but remains on 
stable dose and regimen from Day 24 to Day 37.
Summary of dose and regimen changes will be based on XYWAV Safety analysis set per below:
The time to achieve optimized dose and regimen will be summarized with number of 
participants, mean, SD, median, minimum, maximum.
The number of changes in dose and regimen from first XYWAV dose to achieve optimized dose 
and regimen will be summarized with mean, SD, median, minimum, maximum.
9.1.5.
Characterization of Meals Relative to Dosing
Once a participant has reached optimized dose and regimen, the investigator may decide to 
instruct the participant to dose without regard to food. The number of participants and percentage
in each group (fasted versus without consideration of food), tabulation of the food types (regular 
meal, snack, drink) and percentage will be summarized.
9.1.6.
Sensitivity Analyses
Not applicable
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9.1.7.
Subgroup Analyses
Unless specified, all endpoints will be summarized separately for participants identified as NT1
and NT2. Cataplexy attacks, ESS and PGIc will be summarized separately for those who 
achieved optimized dose and those that did not achieve optimized dose. Summary tables of 
statistics will be produced as described in Sections 9.1.1 through 9.1.3.
9.2.
Exploratory Endpoints
9.2.1.
Ease of Switching Medication Scale (EOSMS)
The EOSMS questionnaire will be administered in electronic format to participants at the ET or 
E/D visits where a participant will evaluate the process of switching from Xyrem to XYWAV 
with one of 5 choices (extremely easy, easy, neither easy nor difficult, difficult, extremely 
difficult). These answers will be tabulated with number and percent for each category of answer
based on XYWAV Safety analysis set. A listing of EOSMS will be presented.
9.2.2.
Forced Preference Questionnaire (FPQ)
FPQ questionnaire are given to participants at the ET or E/D visit where they will give their 
preference of treating their narcolepsy with Xyrem or XYWAV. The preferences will be 
tabulated with number and frequency based on XYWAV Safety analysis set. A listing of FPQ 
will be presented.
10.
SAFETY AND TOLERABILITY
Unless otherwise specified, safety analyses will be based on the safety analysis set. Only 
summary statistics will be provided.
10.1.
Exposure
10.1.1.
Extent of Exposure
Exposure to Xyrem is during in baseline period and exposure to study drug XYWAV is in the 
Open Label Conversion and Treatment Optimization Period (intervention period) (see Section 
5.2). Summary statistics, for the exposure duration (days) for Xyrem during the baseline period 
and XYWAV during the intervention period, number of participants, mean, standard deviation, 
median, and range will be tabulated.
A listing will be produced for both Xyrem and XYWAV exposure details.
10.1.2.
Treatment Compliance
Compliance will be calculated for XYWAV Safety analysis set only.
XYWAV is taken as oral solution at a total salt concentration of 0.5g per mL, Table 2 shows the 
corresponding volume to the assigned dose level. XYWAV compliance will be calculated as the 
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volume of solution taken during a study period (ie, total dispensed – total returned) divided by 
the volume of solution that should have been taken by the participant during that intervention
period, expressed as a percentage:
Compliance (%) =
Volume of solution taken during the intervention period
Volume of solution that should have been taken during the intervention period × 100%
The denominator is the sum of daily volume that should be taken according to the prescribed 
dose and regimen for the day.
Compliance will also be summarized by category (<75%, 75-125% and >125%) for the 
intervention period. A listing of compliance will also be presented. 
Deviations from the prescribed treatment regimen or dosage including overdosing at greater than 
the maximum allowable daily dose of 9 grams or any single dose exceeding 6 grams will be 
summarized.
Table 2
Total Daily Volume of Solution (mL)
Assigned or Stable Dose of Study Drug (g)
Volume of Solution (mL)
4.5
9
5.0
10
5.5
11
6.0
12
6.5
13
7.0
14
8.0
16
9.0
18
10.2.
Adverse Events
Adverse events (AEs) occurring from the initial participant ICF signature date until the end of 
Safety Follow-up visit will be reported. If the Investigator becomes aware of a serious adverse 
event (SAE) within 30 days after the last dose of study drug XYWAV, the event must also be 
reported. In addition, any SAE assessed as related to study drug or procedure by the Investigator 
must be reported regardless of time elapsed after study termination.
Adverse events recorded in the case report form will be coded to system organ class (SOC) and 
preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), Version 24.0.
The investigator will assess the relationship of each AE to study drug. AE with a missing 
relationship to study drug will be reported as related in the summaries. Severity, as determined 
by the Investigator using National Cancer Institute (NCI) common terminology criteria for 
adverse events (CTCAE) version 5.0 or higher, will be classed as mild, moderate, severe, life-
threatening or fatal. An AE with missing severity will be reported as missing in the summaries.
Note that participants who acquire COVID-19 or report AEs due to the COVID-19 public health 
emergency (eg anxiety) while on study will be coded accordingly and included in the adverse 
event summaries. 
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
22 
AEs are defined in this study as follows (Protocol Appendix 7): 
x
A ‘Xyrem-emergent AE’ refers to an AE that began or worsened in the period following 
signing of the informed consent and before administration of the first study intervention 
(XYWAV) dose (i.e., including the Screening period through the Baseline [Xyrem-stable 
dose and regimen] period till the first dose of XYWAV) 
x
A treatment-emergent adverse event (TEAE) refers to an AE that either began or 
worsened after administration of the first dose of study intervention drug (XYWAV) to 
End of Treatment (ET) period (prior to the Safety Follow-up period). 
x
Safety follow-up AEs are defined as occurring after the last dose date until 30 days after 
the last dose date 
x
Unless specified, the term AEs will include both Xyrem-emergent AEs, TEAEs and 
Safety follow-up AEs.
x
Safety follow-up AEs will not be considered as either Xyrem-emergent AEs or TEAE.
They will not be included into summary tables but will be presented in listings.
x
Xyrem-emergent AE related summaries will be based on safety analysis set.
x
TEAE related summaries will be based on XYWAV Safety analysis set.
An overall summary on Xyrem-emergent AE and TEAE with following categories will be 
provided:
x
Subjects with any Xyrem-emergent AE/TEAE
x
Subjects with any drug-related Xyrem-emergent AE/TEAE
x
Subjects with any serious Xyrem-emergent AE/TEAE
x
Subjects with any Xyrem-emergent AE/TEAE by severity 
x
Subjects with any Xyrem-emergent AE/TEAE with outcome as death 
x
Subjects with any Xyrem-emergent AE/TEAE leading to drug withdrawal 
x
Subjects with any Xyrem-emergent AE/TEAE leading to drug dose reduction
x
Subjects with any Xyrem-emergent AE/TEAE leading to drug dose increase
x
Subjects with any Xyrem-emergent AE/TEAE leading to drug interruption
In addition, subject incidence of Xyrem-emergent AEs/TEAEs will be summarized by following:
x
SOC and PT
x
PT only
x
Maximum Severity by SOC and PT
x
Drug-related by SOC and PT
x
Xyrem-emergent AE/TEAE leading to drug withdrawal by SOC and PT
For data listings, all following will be presented:
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
23 
x
All AEs
x
AEs with an outcome of death 
x
AEs leading to drug withdrawal
x
Serious AEs
If a participant has multiple events with the same PT occurring in different periods, the event 
will be reported for each of those periods. Participant incidence of AEs by SOC and PT tables 
are sorted by SOCs (alphabetical order) and then by PTs (descending order) within each SOC for 
the overall frequency. For summaries by PT only, PTs will be sorted in descending order of 
overall frequency.
10.3.
Physical Examinations
A complete PE will be done in the screening period where at a minimum, assessments of the 
cardiovascular, respiratory, gastrointestinal and neurological systems; breast and genitourinary 
exams are excluded. Any abnormality identified at the screening PE will be recorded as medical 
history. 
10.4.
Clinical Laboratory Assessment
Clinical laboratory assessments are listed in Table 3 below. Certain clinical laboratory 
assessments (eg, comprehensive metabolic panel, hematology, urinalysis and serum pregnancy 
testing) will be performed for screening purposes only, whereas other clinical laboratory 
assessments (eg, urine drug, and alcohol screening) will be performed at various study time 
points.
Hematology, serum chemistry and urinalysis at screening will be summarized and listed. In data 
listings, any out of reference range values will be flagged as high/low, further clinically 
significant lab results will be flagged in listings if applicable.  
Abnormal laboratory assessments deemed clinically significant by the investigator will be 
reported as an adverse event.
All other laboratory results, including pregnancy test, drug screen, and alcohol screen, will also 
be presented in data listings.
Table 3
List of Laboratory Tests
Hematology: 
-
Complete blood count (CBC), 
including platelet count and white 
blood cell count (WBC) with 
differential
Serum Chemistry: 
-
Albumin (ALB) 
-
Alkaline phosphatase (ALK-P) 
-
Alanine aminotransferase (ALT; 
SGPT) 
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
24 
Urinalysis: 
-
Appearance 
-
Bilirubin 
-
Color 
-
Glucose 
-
Ketones 
-
Nitrite 
-
Occult blood 
-
pH 
-
Protein 
-
Specific gravity 
-
Urobilinogen 
-
Aspartate aminotransferase (AST; 
SGOT) 
-
Blood urea nitrogen (BUN) 
-
Calcium (Ca) 
-
Chloride (Cl) 
-
Creatinine 
-
Creatine kinase 
-
Gamma-glutamyl transferase (GGT) 
-
Globulin 
-
Glucose 
-
Lactate dehydrogenase (LDH) 
-
Phosphorus 
-
Potassium (K) 
-
Sodium (Na) 
-
Magnesium 
-
Total bilirubin 
-
Direct bilirubin 
-
Total cholesterol 
-
Total protein 
-
Triglycerides 
-
Uric acid 
-
Thyroid stimulating hormone 
(TSH)(screening only) 
*Serum Pregnancy Screen
Drug Screen (urine) 
Alcohol Screen
*Pregnancy screening is required for all females of childbearing potential. Female subjects 
who have undergone surgical sterilization, who are post-menopausal (defined as >1 year of 
amenorrhea), who have medically documented ovarian failure (defined as serum estradiol and 
follicle-stimulating hormone [FSH] levels within the institutional postmenopausal range and a 
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10.5.
Pregnancy Testing
Pregnancy testing is required for all females of childbearing potential in the screening period 
unless otherwise exempt (see Table 3).  Additional pregnancy tests may be performed, as 
deemed necessary by the investigator or required by local regulation, to establish the absence of 
pregnancy at any time during the study. A listing of pregnancy results will be presented.
10.6.
Vital Signs
The following vital signs measurements will be reported for this study.
x
Sitting systolic blood pressure (SBP), (millimeter of mercury [mmHg])
x
Sitting diastolic blood pressure (DBP) (mmHg)
x
Sitting heart rate (beats per minute [bpm])
x
Sitting respiratory rate (breaths/minute)
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
25 
x
Body Temperature (°C)
These vital signs will be measured during the screening visit and each in-clinic scheduled visit,
according to the schedule of activities.
The observed and change from baseline vital signs across all study periods will be summarized
by visit. Change from XYWAV Conversion Day will also be summarized for visits after 
conversion. In addition, number and percentages of subjects with at least one abnormal vital 
signs (based on criteria at Table 4 below) will be summarized by visit.
A listing of vital signs with flagged abnormal values will also be presented.
Table 4
Vital Signs Predefined Markedly Abnormal Criteria
Parameter (unit)
Low
High
SBP (mmHg)
< 90 mmHg 
> 140 mmHg; > 160 mmHg
DBP (mmHg)
< 50 mmHg 
> 90 mmHg; > 100 mmHg
Heart rate (bpm)
< 60 bpm
> 100 bpm
Respiratory Rate
< 12 breaths/min
> 20 breaths/min
Temperature (°C)
< 36.0 °C
> 38.0 °C
10.7.
Electrocardiograms
Electrocardiograms will be reported during the Screening visit with the following ECG 
parameters:
x
Overall ECG assessment:
o
Normal
o
Abnormal, not clinically significant
o
Abnormal, clinically significant
A table of summary statistics will contain count and frequency for the discrete variables (normal, 
abnormal/not clinical significant, abnormal/clinical significant) and count. An ECG listing will 
also be presented.
10.8.
Nausea Visual Analog Scale
Tolerability associated with Xyrem and XYWAV will be measured based on an NVAS 
assessment.
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
26 
For NVAS, the baseline value is defined as NVAS evaluation performed daily over the last 7 
days of the Xyrem-stable Baseline Period. For missing NVAS assessment handling, please see 
Section 7.2.4. The NVAS results for the baseline, end of treatment, and the change from the 
baseline period will be summarized with number and frequency of having nausea or not, and the 
mean (SD), median, and range. 95% CI of the mean change in NVAS from the baseline will be 
estimated. A listing will also be presented.
10.9.
Suicidal Ideation and Behavior Risk Monitoring
XYWAV and Xyrem are considered CNS depressants. Columbia-Suicidal Severity Rating Scale 
(C-SSRS) will be administered to participants during the screening period to exclude any 
individuals with active suicidal ideation or behavior. A listing of C-SSRS scores will be 
presented.
10.10.
Participant Health Questionnaire-9
The Participant Health Questionnaire-9 (PHQ-9) scale is a depression assessment that scores 
each of the 9 DSM-IV criteria for major depressive disorder with 4 scores (0 = not at all, 
1 = several days, 2 = more than half of the days, 3 = nearly every day). Total scores are summed
up to 27 across all 9 criteria with higher score suggesting a more depressed condition. For score 
interpretation, total PHQ-9 scores can be divided into 5 depression severity grades: 1-4 (minimal 
depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe 
depression) and 20-27 (severe depression). 
A table with summary statistics for total scores and overall score interpretation categories will be 
presented. A listing will also be presented.
11.
PHARMACOKINETIC ANALYSES
Not applicable.
12.
PHARMACODYNAMIC ANALYSES 
Not applicable.
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
27 
APPENDICIES
Appendix 1.1:
Adverse Event Date Imputation Rules
Missing AE start dates will be imputed in the ADaM datasets for AE. However, missing AE end 
dates will not be imputed. After imputation based on rules below, if the imputed AE start date is 
after the AE end date, the start date will be imputed by the AE end date further.
Incomplete Adverse Event Start Date
If year is missing (or completely missing): 
o
If AE end date is also missing or AE end date ILUVW;<:$9GRVHGDWHset to 
the first XYWAV dose date.
o
If AE end date < the first XYWAV dose date: set to the informed consent date.
If (year is present and month and day are missing) or (year and day are present and month
is missing):
o
If year = year of the first XYWAV dose: set the date to the first XYWAV dose 
date.
o
If year < year of the first XYWAV dose: set month and day to December 31st,
compare with inform consent date, take the later one.
o
If year > year of the first XYWAV dose: set month and day to January 1st,
compare with last known study date (including follow up period), take the earlier
one.
If month and year are present and day is missing:
o
If year = year of first XYWAV dose, and:
-
If month = month of first XYWAV dose: set day to day of first 
XYWAV dose.
-
If month < month of first XYWAV dose: set day to last day of 
month, compare with inform consent date, take the later one.
-
If month > month of first XYWAV dose: set day to 1st day of 
month, compare with last known study date (including follow up 
period), take the earlier one.
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
28 
o
If year < year of first XYWAV dose: set day to last day of month, compare with 
inform consent date, take the later one.
o
If year > year of first XYWAV dose: set the drug to XYWAV and set day to 1st
day of month, compare with last known study date (including follow up period), 
take the earlier one.
For all other cases: set to date of first XYWAV dose.
 
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
29 
Appendix 2.2:
Prior/Concomitant Medications Date Imputation Rules
Partially missing start/end dates for prior/concomitant medications will be imputed in the ADaM 
dataset for prior/concomitant medications/procedures. If the imputed start date is after the end
date based on rules below, the start date will be imputed by the end date further.
Incomplete Prior/Concomitant Medication Start Date
If year is missing (or completely missing): do not impute.
If (year is present and month and day are missing) or (year and day are present and month
is missing):
Set month and day to January 1st.
If year and month are present and day is missing:
Set day to 1st day of month.
Incomplete Prior/Concomitant Medication End Date
Do not impute if Ongoing Flag is checked.
If year is missing (or completely missing): do not impute.
If (year is present and month and day are missing) or (year and day are present and month
is missing):
Set month and day to December 31st.
If year and month are present and day is missing:
Set day to last day of the month. 
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Jazz Pharmaceuticals
Statistical Analysis Plan – Protocol JZP258-401-00
30 
Appendix 2:
Listing of Anticataplectics and Stimulants
Below are the medication names that are considered as anticataplectics, stimulants/alerting 
agents:
Anticataplectic:
Xyrem
Anticataplectic /Alerting agent:
Pitolisant (Wakix)
Atomoxetine (Strattera) 
Anticataplectic:
Agomelatine
Amitriptyline
Atomoxetine (Strattera)
Bupropion (Wellbutrin)
Citalopram (Celexa)
Clomipramine (Anafranil)
Desipramine
Duloxetine (Cymbalta)
Escitalopram (Cipralex, Lexapro)
Fluoxetine (Prozac)
Imipramine
Mirtazapine
Moclobemid
Paroxetine (Paxil)
Protriptyline (Vivactil)
Reboxetine (Edronax)
Venlafaxine (Argofan, Effexor, Trevilor)
Stimulant/Alerting agent:
Amfetamine
Amfetamine Aspartate
Amfetamine Sulfate
Armodafinil
Atomoxetine
Dexamfetamine
Dexamfetamine Saccharate
Dexamfetamine Sulfate
Dextroamphetamine - amphetamine salt
Dexmethylphenidate
Dexmethylphenidate Hydrochloride
Lisdexamfetamine Mesilate
Mazindol
Methamphetamine
Methylphenidate
Methylphenidate Hydrochloride
Modafinil
Pitolisant
Pitolisant Hydrochloride
Solriamfetol
This list can be updated as the study progresses. All recorded medications will be reviewed by 
clinical development on an ongoing basis. The final list of anticataplectics and 
stimulants/alerting agents will be maintained by data management.
 
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other electronic notices and disclosures that we will provide to you, please confirm that you have 
read this ERSD, and (i) that you are able to print on paper or electronically save this ERSD for 
your future reference and access; or (ii) that you are able to email this ERSD to an email address 
where you will be able to print on paper or save it for your future reference and access. Further, 
if you consent to receiving notices and disclosures exclusively in electronic format as described 
herein, then select the check-box next to ‘I agree to use electronic records and signatures’ before 
clicking ‘CONTINUE’ within the DocuSign system. 
By selecting the check-box next to ‘I agree to use electronic records and signatures’, you confirm 
that: 
x 
You can access and read this Electronic Record and Signature Disclosure; and 
x 
You can print on paper this Electronic Record and Signature Disclosure, or save or send 
this Electronic Record and Disclosure to a location where you can print it, for future 
reference and access; and 
x 
Until or unless you notify Jazz Pharmaceuticals as described above, you consent to 
receive exclusively through electronic means all notices, disclosures, authorizations, 
acknowledgements, and other documents that are required to be provided or made 
available to you by Jazz Pharmaceuticals during the course of your relationship with Jazz 
Pharmaceuticals. 
x 
You are the user identified and that you are applying to use electronic signatures at Jazz 
Pharmaceuticals. Your first and last names and assigned user name are correct. You 
hereby agree to use the combination of my assigned user name and associated private 
password as my electronic signature to review and approve documents that require my 
signature. You further agree that this electronic signature shall be the legally binding 
equivalent of my handwritten signature. You understand that you are accountable and 
responsible for any actions on documents that you initiate under your electronic 
signature. 
CCI