Clinical trial NCT02851407
Conditions: Veno-occlusive Disease
Keywords: stem cell transplant hematopoietic stem cell transplant (HSCT) veno-occlusive disease (VOD) sinusoidal obstruction syndrome (SOS)
Sponsor: Jazz Pharmaceuticals
Start date: 2016-09-01; Completion date: 2020-10-20
Enrollment: 372 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

Detailed description:

Arms: arm 1: Defibrotide is administered intravenously at a dose of 25 mg/kg/day in addition to best supportive care on the day before the first day of the conditioning regimen and will continue (for those patients without a VOD diagnosis) for a recommended minimum of 21 days and end no later than Day +30 post HSCT arm 2: Best supportive care alone (without the addition of defibrotide) according to institutional guidelines and patient need, is administered on the first day of conditioning and will continue until Day +30 post HSCT or hospital discharge, whichever is sooner, or diagnosis of VOD, if applicable
Interventions: intervention 1: Defibrotide intervention 2: Best Supportive Care
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
Confidential 
1 
 
STATISTICAL ANALYSIS PLAN 
 
VERSION: 2.0 
DATE: 24NOV2020 
 
 
 
STUDY DRUG: 
Defibrotide (defibrotide sodium)  
 
 
PROTOCOL/STUDY NUMBER: 
15-007 Protocol Amendment 3 v4.0 (20-AUG-2018) 
 
 
STUDY TITLE: 
A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs 
Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and 
Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant 
 
 
SPONSOR: 
Jazz Pharmaceuticals 
3170 Porter Dr, Palo Alto, CA 94304 
 
 
 
This study is being conducted in compliance with good clinical practice, including the archiving 
of essential documents. 


Defibrotide (JZP-381) 
 
Jazz Pharmaceuticals, Inc. 
Statistical Analysis Plan: 15-007 Version 2.0 
 
24NOV2020 
 
Confidential 
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Defibrotide (JZP-381) 
 
Jazz Pharmaceuticals, Inc. 
Statistical Analysis Plan: 15-007 Version 2.0 
 
24NOV2020 
 
Confidential 
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TABLE OF CONTENTS 
1 
List of Abbreviations ............................................................................................................................. 7 
2 
Modification History ............................................................................................................................. 8 
3 
Purpose ................................................................................................................................................. 9 
4 
Study Design.......................................................................................................................................... 9 
4.1 
Study Design.................................................................................................................................. 9 
4.2 
Study Objectives ......................................................................................................................... 10 
4.2.1 
Primary Objective ................................................................................................................ 10 
4.2.2 
Secondary Objectives .......................................................................................................... 10 
4.2.3 
Exploratory Objectives ........................................................................................................ 11 
4.3 
Study Endpoints .......................................................................................................................... 11 
4.3.1 
Primary Endpoint ................................................................................................................ 11 
4.3.1.1 
Primary Study Hypothesis ............................................................................................... 12 
4.3.2 
Secondary Endpoints .......................................................................................................... 12 
4.3.2.1 
Key Secondary Endpoint ................................................................................................. 12 
4.3.2.2 
Key Secondary Study Hypothesis .................................................................................... 12 
4.3.2.3 
Other Secondary Endpoints ............................................................................................ 12 
4.3.3 
Exploratory Endpoints ......................................................................................................... 13 
4.4 
Study Treatments ........................................................................................................................ 13 
4.5 
Randomization Procedures and Blinding .................................................................................... 14 
4.6 
Determination of the Sample Size .............................................................................................. 14 
4.7 
Planned Interim Analyses and Reviews ...................................................................................... 14 
4.8 
DMC Safety Reviews ................................................................................................................... 15 
5 
Changes in the Conduct of Planned Analyses ..................................................................................... 15 
6 
Study Analysis Sets .............................................................................................................................. 15 
6.1 
Screened Analysis Set ................................................................................................................. 15 
6.2 
Intent-to-Treat Analysis Set (ITT) ................................................................................................ 15 
6.3 
Modified Intent-to-Treat Analysis Set (mITT) ............................................................................. 16 
6.4 
Safety Analysis Set ...................................................................................................................... 16 
6.5 
PK Analysis Set ............................................................................................................................ 16 
6.6 
PK Evaluable Analysis Set ............................................................................................................ 16 
7 
General Considerations ....................................................................................................................... 16 


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7.1 
General Methods ........................................................................................................................ 16 
7.2 
Multiple Comparisons and Multiplicity ....................................................................................... 17 
8 
Data Handling Conventions ................................................................................................................ 17 
8.1 
Missing Data ................................................................................................................................ 17 
8.1.1 
Imputation of Non-Date Missing Data ................................................................................ 17 
8.1.2 
Imputation of Partial Dates ................................................................................................. 18 
8.1.2.1 
Incomplete and Missing Adverse Event Start Date ......................................................... 18 
8.1.2.2 
Incomplete and Missing Prior and Concomitant Medication Start Date ........................ 18 
8.1.2.3 
Incomplete and Missing Prior and Concomitant Medication End Date ......................... 19 
8.2 
Baseline and Study Day Definitions ............................................................................................ 19 
8.2.1 
Baseline Date (Study Day 1) ................................................................................................ 19 
8.2.2 
Baseline Value ..................................................................................................................... 19 
8.2.3 
Day +0 Post-HSCT ................................................................................................................ 19 
8.2.4 
Day +X Post-HSCT ................................................................................................................ 19 
8.2.5 
Post-VOD Treatment Day .................................................................................................... 20 
8.3 
Study Phase ................................................................................................................................. 20 
8.4 
Visit Windows ............................................................................................................................. 20 
8.4.1 
Laboratory Parameters ....................................................................................................... 20 
8.4.2 
Karnofsky and Lansky Performance Scores ........................................................................ 22 
8.4.3 
Vital Signs ............................................................................................................................ 23 
9 
Study Population Summaries .............................................................................................................. 23 
9.1 
Enrollment................................................................................................................................... 23 
9.2 
Disposition .................................................................................................................................. 24 
9.2.1 
Subject Disposition .............................................................................................................. 24 
9.2.2 
Study Treatment Disposition during Prophylaxis Phase ..................................................... 24 
9.2.3 
Study Treatment Disposition during Rescue Phase ............................................................ 25 
9.3 
Protocol Deviations ..................................................................................................................... 25 
9.4 
Demographics and Baseline Characteristics ............................................................................... 25 
9.4.1 
Demographics and Baseline Characteristics ....................................................................... 25 
9.4.2 
Transplant Characteristics ................................................................................................... 26 
9.4.3 
Medical History ................................................................................................................... 27 
9.5 
Prior and Concomitant Medications ........................................................................................... 28 
10 Efficacy ................................................................................................................................................ 28 


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10.1 
Analysis of Primary Endpoint ...................................................................................................... 29 
10.1.1 
Sensitivity Analyses of Primary Endpoint ............................................................................ 32 
10.1.1.1 
Sensitivity Analysis I: Early Termination before Day +30 post-HSCT .......................... 32 
10.1.1.2 
Sensitivity Analysis II: CMH Test on the Composite Event Rate ................................. 33 
10.1.1.3 
Sensitivity Analysis III: Unstratified Log Rank Test ...................................................... 33 
10.1.1.4 
Sensitivity Analysis IV: Stratified Log Rank Test in the mITT Analysis Set ................... 33 
10.1.1.5 
Sensitivity Analysis V: Log Rank Test on VOD-free Survival by Day +30 post-HSCT 
(with EPAC Assessment Only) ......................................................................................................... 34 
10.1.2 
Subgroup Analyses of Primary Endpoint ............................................................................. 34 
10.1.3 
Concordance between Investigator and EPAC Assessed VOD by Day +30 post-HSCT ....... 35 
10.2 
Analysis of Secondary Endpoints ................................................................................................ 36 
10.2.1 
Key Secondary Efficacy Endpoint ........................................................................................ 36 
10.2.2 
Other Secondary Efficacy Endpoints ................................................................................... 36 
10.2.2.1 
Incidence of VOD by Day +30 post-HSCT .................................................................... 36 
10.2.2.2 
VOD-Free Survival by Day +180 post-HSCT ................................................................. 36 
10.2.2.3 
Non-Relapse Mortality by Days +100 and +180 post-HSCT ........................................ 37 
10.2.2.4 
Incidence of VOD-associated MOD by Days +30 and +100 post-HSCT ....................... 37 
10.2.2.5 
Resolution of VOD by Day +180 post-HSCT and Time to Resolution of VOD.............. 38 
10.2.2.6 
Incidence of VOD by Day +100 post-HSCT and Day +180 post-HSCT.......................... 39 
11 Safety .................................................................................................................................................. 39 
11.1 
Extent of Exposure ...................................................................................................................... 39 
11.2 
Adverse Events ............................................................................................................................ 39 
11.2.1 
Adverse Events of Special Interest ...................................................................................... 41 
11.3 
Laboratory Assessments ............................................................................................................. 42 
11.4 
Vital Signs .................................................................................................................................... 43 
11.5 
Graft-versus-Host Disease ........................................................................................................... 44 
11.6 
Graft Failure and Time to Neutrophil and Platelet Engraftment ................................................ 44 
11.7 
Karnofsky and Lansky Performance Scores ................................................................................ 45 
11.8 
Abdominal Ultrasound ................................................................................................................ 46 
12 Hospital Resource Utilization .............................................................................................................. 46 
13 Health-Related Quality of Life ............................................................................................................. 47 
13.1 
EQ-5D-5L ..................................................................................................................................... 47 
13.1.1 
EQ-5D-5L Dimension ........................................................................................................... 47 


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13.1.2 
EQ VAS Score ....................................................................................................................... 48 
13.2 
EQ-5D-Y ....................................................................................................................................... 48 
13.2.1 
EQ-5D-Y Dimension ............................................................................................................. 48 
13.2.2 
EQ VAS Score ....................................................................................................................... 48 
13.3 
EQ-5D-Y Proxy Version 1 ............................................................................................................. 49 
13.3.1 
EQ-5D-Y Proxy Version 1 Dimension ................................................................................... 49 
13.3.2 
EQ VAS Score ....................................................................................................................... 49 
14 Biomarkers .......................................................................................................................................... 49 
15 Immunogenicity .................................................................................................................................. 49 
16 Pharmacokinetic Analyses .................................................................................................................. 50 
16.1 
General Considerations ............................................................................................................... 50 
16.2 
Defibrotide Plasma Concentrations ............................................................................................ 50 
16.3 
Defibrotide Pharmacokinetic Parameters .................................................................................. 52 
17 Pharmacodynamic Analyses ............................................................................................................... 55 
18 Covid-19 .............................................................................................................................................. 55 
19 References .......................................................................................................................................... 56 
20 Appendix I: Prefferred Terms for Adverse Events of special Interest ................................................. 57 
20.1 
PTs for Pulmonary Hemorrhage .................................................................................................. 57 
20.2 
PTs for Gastrointestinal Bleeding ................................................................................................ 57 
20.3 
PTs for Gastrointestinal Bleeding likely pre-existing neurological or neonatal conditions ........ 58 
20.4 
PTs for Hypersensitivity Reactions .............................................................................................. 59 
 
 
 
 


Defibrotide (JZP-381) 
 
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1 LIST OF ABBREVIATIONS 
 
Abbreviation 
Term 
AE 
Adverse event 
AUC 
Area under the curve 
BLQ 
Below the limit of quantitation 
BMI 
Body mass index 
BSC 
Best supportive care 
CDISC 
Clinical Data Interchange Standards Consortium 
CMH 
Cochran-Mantel-Haenszel 
CTCAE 
Common Terminology Criteria for Adverse Events 
DMC 
Data Monitoring Committee 
DP 
Defibrotide prophylaxis 
eCRF 
Electronic case report form 
EDC 
Electronic Data Capture 
EMA 
European Medicines Agency 
EPAC 
Endpoint Adjudication Committee 
FDA 
Food and Drug Administration 
GvHD 
Graft-versus-host disease 
HSCT 
Hematopoietic stem cell transplant 
ICH 
International Council for Harmonisation 
IRT 
Interactive response technology 
ISC 
Independent Statistical Center 
ITT 
Intent-to-treat 
IWRS 
Interactive web response system 
KM 
Kaplan-Meier 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOD 
Multi-organ dysfunction 
NRM 
Non-relapse mortality 
PK 
Pharmacokinetic  
PT 
Preferred term 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 


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SD 
Standard deviation 
SOC 
System organ class 
TEAE 
Treatment-emergent adverse event 
VAS 
Visual analogue scale 
VOD 
Hepatic veno-occlusive disease 
WHO 
World Health Organization 
 
 
 
2 MODIFICATION HISTORY  
 
Version 
Date 
Description  
Original 1.0 
15MAY2020 
 
2.0 
24NOV2020 
Section 5 was updated to describe the following changes in conduct of 
the planned analysis: 
• 
Clarify censoring rules for subjects who do not undergo HSCT 
• 
Add censoring rules for subjects who are diagnosed with VOD 
prior to HSCT 
• 
Clarify the definition of Baseline 
 
Section 10.1.2 was updated to correct the criteria for determining prior 
liver disease by removing the criterion of advanced stage 
neuroblastoma requiring myeloablative conditioning. 
 
Section 16 was updated to account for differences in PK timepoints 
across protocol amendments for samples taken in subjects who 
developed VOD and received defibrotide rescue treatment.  
 
 
 


Defibrotide (JZP-381) 
 
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Statistical Analysis Plan: 15-007 Version 2.0 
 
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3 PURPOSE 
This Statistical Analysis Plan (SAP) provides a detailed and complete description of the planned 
statistical analyses for the final analysis of Study 15-007 to support the Clinical Study Report 
(CSR).  Mock tables, listings, and figures shells will be provided in a separate supporting 
document. 
 
This SAP complies with the International Council for Harmonisation (ICH) Harmonised 
Tripartite Guideline Topic E9, Statistical Principles for Clinical Trials. The current version is 
based on Protocol version 4.0 dated 20 August 2018.   
 
Biomarker and immunogenicity analysis plans and results will be provided in separate 
documents. 
 
All decisions regarding the final analysis of the study results, as defined in this SAP document, 
will be made prior to database freeze of the study data. 
 
4 STUDY DESIGN 
4.1 Study Design 
This is a Phase 3, open-label, randomized study to compare the efficacy and safety of defibrotide 
prophylaxis (DP) vs. best supportive care (BSC) in the prevention of hepatic veno-occlusive 
disease (VOD) as diagnosed using the modified Seattle criteria in adult and pediatric subjects 
undergoing hematopoietic stem cell transplant (HSCT) who are at high risk or very high risk of 
developing VOD. This study has an adaptive design with 1 interim analysis which has been 
detailed in a separate interim SAP.  
A total of 400 subjects are planned for enrollment to ensure completion of approximately 360 
subjects. An interim analysis overseen by an independent Data Monitoring Committee (DMC) is 
planned when 70% of subjects are evaluable for the primary efficacy endpoint (ie, VOD-free 
survival by Day +30 post-HSCT), with prespecified rules for efficacy stop, futility stop, and 
possible sample size re-estimation up to a maximum of 600 subjects total. 
 
After informed consent or assent has been obtained from subjects, or legal parent/guardians or 
representatives, as applicable, screening procedures will be performed within 14 days of the 
scheduled start of the subject’s HSCT conditioning regimen. Eligible subjects will be randomly 
assigned to receive defibrotide prophylaxis 25 mg/kg/day in addition to BSC (DP arm) or BSC 
alone (BSC arm) in a 1:1 ratio.  
 
All subjects enrolled in the study will receive individualized standard of care therapy based on 
local institutional guidelines and subject need. This standard of care therapy or BSC is intended 
to serve as a study control for comparison with those subjects randomized to receive defibrotide 
prophylaxis. Subjects randomized to the BSC arm will receive standard of care therapy per 
institutional guidelines and subject need; subjects randomized to the defibrotide prophylaxis arm 
(DP arm) will also receive standard of care therapy based on local institutional guidelines and 


Defibrotide (JZP-381) 
 
Jazz Pharmaceuticals, Inc. 
Statistical Analysis Plan: 15-007 Version 2.0 
 
24NOV2020 
 
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subject need plus defibrotide prophylaxis. Prophylactic use of defibrotide added to BSC (DP 
arm) will be compared to BSC (BSC arm). 
 
Administration of defibrotide to subjects in the DP arm will begin within 24 hours of the first 
dose of conditioning regimen, and will continue (for those subjects without a VOD diagnosis) for 
a recommended minimum of 21 days and end no later than Day +30 post-HSCT. For subjects in 
the BSC arm, administration of BSC according to institutional guidelines and subject need will 
begin on the first day of conditioning and continue until Day +30 post-HSCT or hospital 
discharge, whichever is sooner, or diagnosis of VOD, if applicable.  
 
If subjects in either the DP or BSC arm develop VOD, per the modified Seattle criteria, they may 
receive rescue defibrotide treatment for VOD as prespecified in the informed consent and/or 
assent forms. For subjects in either arm who develop VOD, defibrotide for treatment of VOD 
should be administered until resolution of VOD or hospital discharge. 
 
Subjects will continue to be monitored for development of late-onset VOD through Day +180 
post-HSCT. Subjects who develop clinical signs and symptoms of VOD after hospital 
discharge/Day +30 post-HSCT will require more frequent monitoring (refer to specific 
instructions within schedule of assessments in the protocol), and re-admission to the hospital will 
be at the investigator’s discretion. 
 
An independent Endpoint Adjudication Committee (EPAC) blinded to study treatment 
assignment will be established to determine whether a subject meets the criteria for VOD by Day 
+30 post-HSCT and by Day +100 post-HSCT, using the modified Seattle criteria. The EPAC 
will review relevant electronic case report forms (eCRFs), results of diagnostic procedures, and 
ultrasound results; alternate etiology (eg, cholecystitis, viral hepatitis, acute graft-versus-host 
disease [GvHD]) will also be considered during review of subject data.  
 
4.2 Study Objectives 
4.2.1 Primary Objective 
The primary objective of the study is to compare the efficacy of defibrotide prophylaxis in 
addition to BSC (DP arm) vs BSC alone (BSC arm) for the prevention of VOD as measured by 
VOD-free survival by Day +30 post-HSCT in subjects who are at high risk or very high risk for 
developing VOD. 
4.2.2 Secondary Objectives 
The key secondary objective of the study is to compare the efficacy of defibrotide prophylaxis in 
addition to BSC (DP arm) vs BSC alone (BSC arm) for the prevention of VOD as measured by 
VOD-free survival by Day +100 post-HSCT in subjects who are at high risk or very high risk for 
developing VOD. 
 
Other secondary objectives of the study are as follows: 
 


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• To further compare the efficacy of defibrotide prophylaxis in addition to BSC (DP arm) vs 
BSC alone (BSC arm) on additional variables as follows: 
o Incidence of VOD by Day +30 post-HSCT 
o VOD-free survival by Day +180 post -HSCT 
o Non-relapse mortality (NRM) by Days +100 and +180 post-HSCT 
o Incidence of VOD-associated multi-organ dysfunction (MOD) (ie, severe VOD) by 
Days +30 and +100 post-HSCT (in those subjects who develop VOD) 
o Resolution of VOD by Day +180 post-HSCT and time to resolution of VOD (in those 
subjects who develop VOD) 
o Incidence of VOD after Day +30 post-HSCT up to Days +100 and +180 post-HSCT 
• To compare the health-related quality of life using the following questionnaires: 
o 5-Level EuroQol-5D (EQ-5D-5L) (adults only) 
o EuroQol-5D for Youth (EQ-5D-Y), proxy version 1 (pediatric subjects 4 to 7 years of 
age) 
o EQ-5D-Y, self-report version 1 (pediatric subjects 8 to <16 years of age) 
• To characterize the pharmacokinetics of defibrotide 
• To compare the overall safety of defibrotide in addition to BSC vs BSC alone, including 
adverse event (AE) profile, serious adverse event (SAE) profile, laboratory abnormalities, 
and vital signs (including peri-infusional vital signs for subjects who receive defibrotide) 
• To compare the overall safety of defibrotide in addition to BSC vs BSC alone by comparing 
the incidence of Grades 2, 3, and 4 acute GvHD by Days +30, +100, and +180 post-HSCT, 
and the incidence of chronic GvHD by Day +180 post-HSCT 
• To compare graft failure and time to neutrophil and platelet engraftment 
4.2.3 Exploratory Objectives 
The exploratory objectives of this study are as follows: 
• To compare the hospital resource utilization for subjects in the DP and BSC arms. 
• To evaluate plasma concentration of potential predictive or prognostic VOD biomarkers 
(which may include, but will not be limited to vascular cell adhesion molecule 1 [VCAM1], 
von Willebrand factor [vWF], L-ficolin, plasminogen activator inhibitor [PAI-1], 
thrombomodulin, C-reactive protein [CRP], angiopoietin 2 [ANG2]) and/or GvHD 
biomarkers (which may include, but will not be limited to tumor necrosis factor receptor 1 
[TNFR1], interleukin-1 receptor-like-1 [IL1RL1, also known as ST2], and regenerating islet-
derived 3-alpha [REG3α]) 
• To evaluate immunogenicity of defibrotide in subjects who receive defibrotide for treatment 
or prophylaxis 
4.3 Study Endpoints 
4.3.1 Primary Endpoint 
The primary efficacy endpoint is VOD-free survival at Day +30 post-HSCT as adjudicated by 
the independent EPAC. An event for the primary efficacy endpoint is defined as a VOD 
diagnosis (as assessed by the EPAC) or death, whichever is earlier, up to and including  Day +30 
post-HSCT. 


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4.3.1.1 Primary Study Hypothesis 
The primary efficacy endpoint is a time-to-event endpoint. The statistical hypothesis for the 
primary endpoint is as follows: 
• Null hypothesis (H0): There is no difference in VOD-free survival by Day +30 post-
HSCT between the DP and the BSC arms. 
 
• Alternative hypothesis (H1):  There is a difference in VOD-free survival by Day +30 
post-HSCT in favor of the DP arm over the BSC arm. 
Superiority will be assessed using data from the intent-to-treat (ITT) analysis set. The study is 
designed with both an interim and a final analysis. To maintain an overall significance level at 1-
sided alpha of 0.025, the incremental alpha is specified at 1-sided 0.0005 for the interim analysis 
and 1-sided 0.0245 for final analysis (the corresponding nominal alpha is 1-sided 0.0005 for 
interim analysis and 1-sided 0.02498 for final analysis). 
4.3.2 Secondary Endpoints 
4.3.2.1 Key Secondary Endpoint 
The key secondary efficacy endpoint is VOD-free survival by Day +100 post-HSCT as 
adjudicated by the independent EPAC. 
4.3.2.2 Key Secondary Study Hypothesis 
The key secondary efficacy endpoint is a time-to-event endpoint. The statistical hypothesis is as 
follows: 
• Null hypothesis (H0): There is no difference in VOD-free survival by Day +100 post-
HSCT between the DP and the BSC arms. 
 
• Alternative hypothesis (H1):  There is a difference in VOD-free survival by Day +100 
post-HSCT in favor of DP arm over BSC arm. 
Superiority will be assessed using data from the ITT analysis set. To control the study-wise type I 
error, a sequential testing strategy will begin with the test on primary efficacy endpoint. If that test 
is significant, the test on the key secondary efficacy endpoint will be conducted at 1-sided alpha = 
0.025. This gate-keeping approach will keep the family-wise error rate at 1-sided 0.025 for the 
comparisons of the 2 treatment arms in the primary and the key secondary efficacy endpoint 
analyses. 
4.3.2.3 Other Secondary Endpoints 
Other secondary efficacy endpoints will be tested without multiplicity adjustments, and nominal 
p-values will be reported. Other secondary efficacy endpoints include the following: 
• Incidence of VOD by Day +30 post-HSCT 
• VOD-free survival by Day +180 post-HSCT 
• NRM by Days +100 and +180 post-HSCT 


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• Incidence of VOD-associated MOD (ie, severe VOD) by Days +30 and +100 post-HSCT (in 
those subjects who develop VOD) 
• Proportion of subjects who have resolution of VOD by Day +180 post-HSCT and time to 
resolution of VOD 
• Incidence of VOD after Day +30 post-HSCT up to Days +100 and +180 post-HSCT 
• Health-related quality of life using EQ-5D-5L (adults only), EQ-5D-Y (proxy version 1; 
pediatric subjects 4 to 7 years of age), and EQ-5D-Y (self-report version 1; pediatric subjects 
8 to <16 years of age) 
• Pharmacokinetics of defibrotide 
• Safety of defibrotide in addition to BSC vs BSC alone, including AE profile, SAE profile, 
laboratory abnormalities, and vital signs 
• Incidence of Grades 2, 3, and 4 acute GvHD by Days +30, +100, and +180 post-HSCT, and 
the incidence of chronic GvHD by Day +180 post-HSCT 
• Graft failure and time to neutrophil and platelet engraftment 
4.3.3 Exploratory Endpoints 
Exploratory endpoints include the following: 
• Hospital resource utilization 
• Evaluate plasma concentration of potential predictive or prognostic VOD biomarkers (which 
may include, but will not be limited to VCAM1, vWF, L-ficolin, PAI-1, thrombomodulin, 
CRP, ANG2) and/or GvHD biomarkers (which may include, but will not be limited to 
TNFR1, IL1RL1 (also known as ST2), and REG3α) 
• Evaluate immunogenicity of defibrotide in subjects who receive defibrotide for treatment or 
prophylaxis 
4.4 Study Treatments 
For subjects randomized to the DP arm, defibrotide solution is administered intravenously by 
study site personnel at a dose of 25 mg/kg/day, divided into 4 equal doses of 6.25 mg/kg/dose 
given as 2-hour infusions every 6 hours. Defibrotide administration is recommended for a 
minimum of 21 days beginning within 24 hours prior to the start of the conditioning regimen (2-
4 doses of defibrotide should be administered within 24 hours prior to conditioning regimen) and 
ending no later than Day +30 post-HSCT. Subjects in this arm of the study will also receive 
standard of care therapy based on local institutional guidelines and subject need. 
 
Subjects randomized to the BSC arm should receive standard of care therapy according to 
institutional guidelines and subject need.  Best supportive care is intended to serve as study 
control for comparison with those subjects randomized to receive DP. Administration of BSC 
will begin on the first day of conditioning and continue until Day +30 post-HSCT or hospital 
discharge, whichever is sooner, or diagnosis of VOD, if applicable. 
 


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4.5 Randomization Procedures and Blinding  
After informed consent or assent has been obtained from subjects, or legal parent/guardians or 
representatives, as applicable, screening procedures will be performed within 14 days of the 
scheduled start of the subject’s HSCT conditioning regimen. Eligible subjects will be randomly 
assigned to receive DP 25 mg/kg/day in addition to BSC (DP arm) or BSC alone (BSC arm) in a 
1:1 ratio. Randomization will be stratified according to risk of developing VOD (high-risk or 
very high-risk), age (>16 years or ≤16 years), and country using an interactive web response 
system (IWRS). Enrollment of those subjects meeting high-risk criteria will be capped at 65% of 
the total enrollment using IWRS. 
 
This is an open-label study. To minimize potential for bias, the following blinding measures will 
be employed: 
• The central reviewer of imaging studies will be blinded to study treatment assignment 
and all non-radiologic subject data (see protocol Section 6.3.1.2). 
• Members of the EPAC will be blinded to study treatment assignment, will not be 
employees of the Sponsor, and will not be otherwise involved in the study (see protocol 
Section 6.3.1.3 and Section 11.9.2). 
4.6 Determination of the Sample Size 
On the basis of literature and results from a previously conducted prevention study (Study 2004-
000592-33) with defibrotide (Corbacioglu et al. 2012), the proposed sample size for this study is 
200 subjects per treatment arm for a total sample size of 400 subjects. Through simulations, it is 
shown that this sample size provides a 90% power to detect a hazard ratio (HR) of 0.46 for 
VOD-free survival by Day +30 post-HSCT in DP arm as compared with BSC arm, with an 
average of 68 events total. The HR of 0.46 is based on 86% and 72% VOD-free survival rates by 
Day +30 post-HSCT for DP arm and BSC arm, respectively, which translate to 14% and 28% as 
the incidence of VOD or death by Day +30 post-HSCT for the 2 arms, respectively. The 
assumptions for the simulations to calculate the sample size also include: (1) a 2-look group 
sequential design at 1-sided significance level of 0.025 (overall) with 1 interim analysis for 
efficacy stopping (1-sided significance level of 0.0005) or nonbinding futility stopping at ≤10% 
conditional power; and (2) 10% dropout rate.  
4.7 Planned Interim Analyses and Reviews 
Due to uncertainties associated with the study design assumptions, specifically the background 
rate of events in the BSC treatment arm and the size of the treatment effect, an interim analysis 
to be overseen by the DMC is planned when 70% of subjects are evaluated for the primary 
efficacy endpoint (ie, VOD-free survival by Day +30 post-HSCT), with specific rules for 
efficacy stop (ie, 1-sided alpha of 0.0005), futility stop (ie, conditional power <10%), and 
possible sample size re-estimation up to a maximum of 600 subjects total when the conditional 
power is in the promising zone. Details on the content of the interim analysis and adaptive design 
decision rules are  provided in the interim Statistical Analysis Plan (iSAP) and specified along 
with the responsibilities of the DMC as part of the DMC charter. 
 


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4.8 DMC Safety Reviews 
The independent DMC will also oversee periodic safety analyses. The periodic safety analyses 
will begin after 50 subjects have been randomly assigned to study treatment and monitored for a 
minimum of 3 months, and will occur approximately every 6 months thereafter. 
 
5 CHANGES IN THE CONDUCT OF PLANNED ANALYSES 
Three TEAEs of special interest (pulmonary hemorrhage, gastrointestinal bleeding, and 
hypersensitivity reactions) will be summarized.  This is not specified in the protocol. 
Section 10.1 clarifies censoring rules for subjects who don’t undergo HSCT. The protocol 
defines the timing variable for these subjects but does not describe how these subjects who are 
not at risk of post-HSCT events should be censored.  
Section 10.1 also added censoring rules for subjects who develop VOD prior to HSCT. This 
scenario is a possible outcome, albeit rare, and was not addressed in the protocol.  
Section 8.2.1 clarifies how baseline is defined. The protocol defines baseline as follows: 
“Baseline/Study Day 1 is defined as the day before conditioning begins for patients randomized 
to the DP arm and the day that conditioning begins for patients randomized to the BSC arm.” As 
the first dose of defibrotide is administered within 24 hours prior to the first dose of conditioning 
for subjects randomized to DP arm, the two definitions should result into the same Study Day 1 
if the subjects strictly follow the protocol. In practice, it is possible that the subjects receive the 
first dose of defibrotide and then do not start conditioning on the next day. Thus, the definition in 
the protocol could result in a baseline assessment that occurs after defibrotide administration 
begins. For safety analyses, the baseline value should be the last assessment taken prior to study 
drug administration. For this reason, the definitions of Baseline/ Study Day 1 and of baseline 
values were further clarified in the SAP and this is the default definition used in the analyses. 
 
6 STUDY ANALYSIS SETS 
6.1 Screened Analysis Set 
The Screened Analysis Set consists of all subjects who provided written informed consent and 
who undergo study screening procedures.  
6.2 Intent-to-Treat Analysis Set (ITT) 
The ITT Analysis Set will include all randomized subjects. This will be the primary analysis set 
for the primary efficacy endpoint and all other efficacy endpoints. Subjects will be analyzed by 
the treatment they were randomized to receive. 


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6.3 Modified Intent-to-Treat Analysis Set (mITT) 
The mITT Analysis Set will include all randomized subjects who proceed to HSCT. This will be 
used in some of the sensitivity analyses. Subjects will be analyzed by the treatment they were 
randomized to receive. 
6.4 Safety Analysis Set 
The overall safety population will include all subjects randomized to the DP arm who receive 
at least 1 dose of defibrotide and all subjects randomized to the BSC arm. Subjects will be 
analyzed by the treatment they actually receive. 
6.5 PK Analysis Set 
The PK Analysis Set will include all subjects who received at least one dose of defibrotide and 
had at least one evaluable defibrotide plasma concentration.  
6.6 PK Evaluable Analysis Set 
The PK Evaluable Analysis Set will include all subjects in the PK Analysis Set who have at least 
one evaluable defibrotide plasma PK parameter. 
 
7 GENERAL CONSIDERATIONS 
7.1 General Methods 
The statistical principles applied in the design and planned analyses of this study are consistent 
with ICH E9 guidelines (ICH 1998). 
Analysis datasets will be created according to Clinical Data Interchange Standards Consortium 
(CDISC) standards. SAS® version 9.3 (or higher) will be used to perform all data analyses and 
to generate tables, figures, and listings.  
Summaries will order the treatment display from left to right as follows: DP (study treatment), 
BSC (control), and Total if a total column if applicable. Listings will include the randomized 
treatment arm, unique subject number, age, gender, and race. They will be sorted by treatment 
arm and then by subject number within treatment arm.  
Unless otherwise specified, continuous data will be summarized using descriptive statistics 
comprising the number of subjects with data to be summarized (n), mean, standard deviation 
(SD), median, minimum (min) and maximum (max). Categorical variables will be presented 
using counts and percentages. Every category will be kept in the summary even if it has 0 
subjects. Summary statistics of central tendency will be reported to one more decimal place than 
the collected data.  Summary statistics of variability will be reported to one more decimal place 
than the commensurate measure of central tendency.  For example, the mean and median for age 
will be reported to one decimal place because it is collected in full years.  The standard deviation 


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of age will then be reported to 2 decimal places. P-values > 0.9999 will be presented as 
‘>0.9999’ and p-value < 0.0001 will be presented as ‘< 0.0001’. 
Subjects will be stratified at randomization according to country, risk of developing VOD (high 
risk or very high risk), and age (>16 years or ≤16 years). Analyses and summaries using the ITT 
and mITT analysis sets will be stratified using stratification data reported in the Interactive 
Response Technology (IRT) system at the time of randomization. Analyses and summaries using 
the Safety analysis set will be stratified using data reported in the Electronic Data Capture (EDC) 
system. If the number of subjects with discrepancies between IRT and EDC with regard to 
stratum assignment is greater than or equal to 5% of the randomized subjects, the primary and 
key secondary efficacy endpoint analyses will be repeated using the stratum assignment reported 
in EDC as sensitivity analyses. A listing of the discrepancies between IRT and EDC with regard 
to stratum assignment will be provided.  
7.2 
Multiple Comparisons and Multiplicity 
The primary objective of the study is to compare the efficacy of DP in addition to BSC (DP arm) 
vs BSC alone (BSC arm) for the prevention of VOD as measured by VOD-free survival by Day 
+30 post-HSCT in subjects who are at high risk or very high risk for developing VOD. The study 
is designed with both an interim and a final analysis. To maintain an overall significance level at 
1-sided alpha of 0.025, the incremental alpha is specified at 1-sided 0.0005 for interim analysis 
and 1-sided 0.0245 for final analysis (the corresponding nominal alpha is 1-sided 0.0005 for 
interim analysis and 1-sided 0.02498 for final analysis). 
 
The key secondary objective of the study is to compare the efficacy of DP in addition to BSC 
(DP arm) vs BSC alone (BSC arm) for the prevention of VOD as measured by VOD-free 
survival by Day +100 post-HSCT in subjects who are at high risk or very high risk for 
developing VOD. To control the study-wise type I error, a sequential testing strategy will begin 
with the test on primary efficacy endpoint. If the test is significant, the test on the key secondary 
efficacy endpoint will be conducted at 1-sided alpha = 0.025. This gate-keeping approach will 
keep the family-wise error rate at 1-sided 0.025 for the comparisons of the 2 treatment arms in 
the primary and the key secondary efficacy endpoint analyses. 
 
Other endpoints including secondary efficacy endpoints will be tested without multiplicity 
adjustments, and nominal p-values will be reported. 
 
8 DATA HANDLING CONVENTIONS 
8.1 Missing Data  
8.1.1 Imputation of Non-Date Missing Data 
Missing data occurs when any requested data is not provided, leading to blank fields on the 
collection instrument. These data will be indicated by the use of a “blank” in subject listing 
displays. Note that if any missing data is imputed, the imputed data will only be used in 


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summaries, and will not be included in any listing. Answers such as “Not applicable” and “Not 
evaluable” are not considered to be missing data and should not be displayed as missing. 
Subjects with the designation of treatment relationship for AEs and SAEs missing will have the 
worst case assumed to impute the relationship: if relationship to study treatment is missing it will 
be assumed to be “Yes”. There will be no other imputation for missing data other than as 
described in Section 8.1.2 for partial dates and times. 
8.1.2 Imputation of Partial Dates 
8.1.2.1 Incomplete and Missing Adverse Event Start Date 
The following imputation rules will be followed, when the AE start date is incomplete (eg, only 
year is present, but month and day are missing) or completely missing: 
• If year is missing (including the situation where the start date is completely missing), set 
the date to the first dose 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 first dose, set the date to the first dose date; 
o if year < year of first dose, set month and day to December 31st; 
o if year > year of first dose, set month and day to January 1st.  
• If year and month are present, and day is missing, 
o if year = year of first dose, and 
 if month = month of first dose, set day to day of first dose; 
 if month < month of first dose, set day to the last day of month; 
 if month > month of first dose, set day to the first day of month; 
o if year < year of first dose, set day to the last day of month; 
o if year > year of first dose, set day to the first day of month. 
• For all other cases that are not covered above, set the date to the first dose date. 
8.1.2.2 Incomplete and Missing Prior and Concomitant Medication Start Date 
The following imputation rules will be followed, when the prior and concomitant medication 
start date is incomplete (eg, only year is present, but month and day are missing) or completely 
missing: 
• If year is missing (including the situation where the start date is completely missing), do 
not impute, and the start date will be treated as missing in the analysis. 
• 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 the first day of month. 


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8.1.2.3 Incomplete and Missing Prior and Concomitant Medication End Date 
The following imputation rules will be followed, when the prior and concomitant medication end 
date is incomplete (e.g., only year is present, but month and day are missing) or completely 
missing: 
• If it is indicated that the medication is ongoing (ie, “Yes” is checked for the question 
“Ongoing?” in the CRF), do not impute, since there should not be an end date for this 
medication. 
• If year is missing (including the situation where the end date is completely missing), do 
not impute, and the end date will be treated as missing in the analysis. 
• 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 the last day of month. 
8.2 Baseline and Study Day Definitions 
8.2.1 Baseline Date (Study Day 1) 
Baseline is defined as the earliest date of the first dose of defibrotide or conditioning therapy. 
8.2.2 Baseline Value 
For assessments where time was collected for both the assessment and the first dose, the baseline 
value is defined as the last nonmissing value collected on or before the time of the first dose. For 
assessments where time was not collected, the baseline value is defined as the last nonmissing 
value collected on or before the date of the first dose. For subjects who do not have at least one 
dose of defibrotide or conditioning therapy, the baseline value is defined as the value that was 
collected where nominal Visit = Baseline. If this value is missing, then baseline value is defined 
as the value collected where Visit = Screening.  
8.2.3 Day +0 Post-HSCT  
Day +0 post-HSCT is defined as the 0th day after HSCT; that is, the day of HSCT. For subjects 
in the ITT Analysis Set who do not have HSCT, Day +0 post-HSCT is the 0th day after 
randomization; that is, the day of randomization. For the analyses of all efficacy endpoints, 
duration calculations will start at Day +0 post-HSCT. 
8.2.4 Day +X Post-HSCT  
Day +X post-HSCT is defined as the Xth day after the date of Day +0 post-HSCT, where X is a 
positive integer representing the number of days to an event. For subjects who do not undergo 
HSCT, Day +X post-HSCT is the Xth day after the date of randomization. Day +X post-HSCT 
for an event is calculated as follows: 
X = [Date of the event] – [Date of Day +0 post-HSCT] 


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8.2.5 Post-VOD Treatment Day 
Day +0 post-VOD Treatment is defined as the VOD Treatment initiation date after VOD 
diagnosis. Post-VOD Treatment day is calculated relative to Day +0 post-VOD Treatment. For 
events that occurred after the VOD Treatment date (i.e. Day +X post-VOD Treatment), the day is 
calculated as follows: 
X = [Date of the event] – [Date of Day +0 post-VOD Treatment] 
8.3 Study Phase  
In this study, the occurrence of VOD and the administration of rescue defibrotide represent a 
clinical landmark time point for safety. Therefore, for the safety analyses, 2 study phases are 
defined with respect to the administration of rescue defibrotide, as follows: 
• Prophylaxis Phase:  
o If VOD occurs, the prophylaxis phase starts on the Baseline date and ends on the 
day before the start date of rescue defibrotide (ie, rescue treatment start date – 1). 
o If VOD does not occur, the prophylaxis phase starts on the Baseline date and ends 
on the date of study completion/early termination. 
• Rescue Treatment Phase:  
o For the subset of subjects who developed VOD and received rescue defibrotide, 
the rescue treatment phase begins on the start date of rescue defibrotide and ends 
on the date of study completion/early termination.  
The start date of rescue defibrotide will be derived as the date of the first administration of 
defibrotide on or after the investigator diagnosis of VOD.  
Unless otherwise noted, safety summaries will be reported by study phase and by treatment 
received during the Prophylaxis Phase. 
8.4 Visit Windows 
Visit windows will be defined for the purpose of classifying assessments to be used in the 
analysis in the case that an assessment is obtained outside scheduled assessment times or if 
multiple assessments are collected. If multiple valid nonmissing assessments exist in an analysis 
window, then the following rules will be used to choose the assessment for the analyses: 
• The assessment on the date closest to the date of the nominal day of that visit will be 
selected. 
• If there are 2 assessments with equal distance from the nominal day, the one on the latest 
date will be selected. 
• If there is more than 1 assessment on the selected date, the average will be taken and used 
for the analyses. 
8.4.1 Laboratory Parameters  
For the laboratory (hematology, coagulation and chemistry) parameters, Table 1 below provides 
the analysis windows for the purpose of identifying the assessments to be used in the analyses 
during the prophylaxis phase. Table 2 provides the analysis windows for the rescue phase.  


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Table 1 - Analysis Window for Laboratory Parameters During Prophylaxis Phase 
Visit Identifier 
Nominal Day 
Lower Limit: 
HSCTSTDY 
Upper Limit: 
HSCTSTDY 
Baseline 
The last nonmissing value collected on or 
before the first dose. 
Day +1 post-HSCT 
HSCTSTDY=2 
1 
4 
Day +7 post-HSCT 
HSCTSTDY=8 
5 
11 
Day +14 post-HSCT 
HSCTSTDY=15 
12 
18 
Day +21 post-HSCT 
HSCTSTDY=22 
19 
25 
Day +30 post-HSCT 
HSCTSTDY=31 
26 
34 
Day +37 post-HSCT 
HSCTSTDY=38 
35 
41 
Day +44 post-HSCT 
HSCTSTDY=45 
42 
48 
Day +51 post-HSCT 
HSCTSTDY=52 
49 
55 
Day +60 post-HSCT 
HSCTSTDY=61 
56 
66 
Day +100 post-HSCT 
HSCTSTDY=101 
96 
106 
Day +180 post-HSCT 
HSCTSTDY=181 
171 
191 
HSCTSTDY = DATE – (Date of Day +0 post-HSCT) + 1, where DATE is the date of the lab assessment. 
 
 
Table 2 - Analysis Window for Laboratory Parameters During Rescue Phase 
Visit Identifier 
Nominal Day 
Lower Limit: 
HSCTSTDY 
Upper Limit: 
HSCTSTDY 
Baseline 
The last nonmissing value collected on 
or before the first dose. 
Day +1 post-VOD Treatment 
HSCTSTDY=2 
1 
4 
Day +7 post-VOD Treatment 
HSCTSTDY=8 
5 
11 


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Day +14 post-VOD Treatment 
HSCTSTDY=15 
12 
18 
Day +21 post-VOD Treatment 
HSCTSTDY=22 
19 
25 
Day +30 post-VOD Treatment 
HSCTSTDY=31 
26 
34 
Day +37 post-VOD Treatment 
HSCTSTDY=38 
35 
41 
Day +44 post-VOD Treatment 
HSCTSTDY=45 
42 
48 
Day +51 post-VOD Treatment 
HSCTSTDY=52 
49 
55 
Day +60 post-VOD Treatment 
HSCTSTDY=61 
56 
64 
Day +67 post-VOD Treatment 
HSCTSTDY=68 
65 
71 
Day +30 post-HSCTa 
HSCTSTDY=31 
26 
34 
Day +100 post-HSCTa 
HSCTSTDY=101 
96 
106 
Day +180 post-HSCTa 
HSCTSTDY=181 
171 
191 
HSCTSTDY = DATE – (Date of Day +0 post-VOD Treatment) + 1, where DATE is the date of the lab 
assessment. 
a HSCTSTDY = DATE – (Date of Day +0 post-HSCT) + 1, where DATE is the date of the lab assessment. If Day 
+30, +100 or +180 post-HSCT visit occurs during the Rescue Phase, the corresponding records will be 
summarized twice (once at post-VOD Treatment summary and once at post-HSCT summary). 
 
8.4.2 Karnofsky and Lansky Performance Scores 
For the Karnofsky and Lansky performance scores, Table 3 provides the analysis windows for 
the purpose of identifying the assessments to be used in the analyses. 
 
Table 3 - Analysis Window for Karnofsky and Lansky Performance Scores 
Visit Identifier 
Nominal Day 
Lower Limit: 
HSCTSTDY 
Upper Limit: 
HSCTSTDY 
Baseline 
The last nonmissing value collected on or 
before the first dose. 
Day +0 post-VOD Treatment a 
HSCTSTDY=1 
1 
4 
Day +1 post-HSCT 
HSCTSTDY=2 
2 
5 
Day +7 post-HSCT 
HSCTSTDY=8 
6 
12 


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Day +15 post-HSCT 
HSCTSTDY=15 
13 
25 
Day +30 post-HSCT 
HSCTSTDY=31 
26 
51 
Day +60 post-HSCT 
HSCTSTDY=61 
52 
81 
Day +100 post-HSCT 
HSCTSTDY=101 
82 
141 
Day +180 post-HSCT 
HSCTSTDY=181 
142 
191 
HSCTSTDY = DATE – (Date of Day +0 post-HSCT) + 1, where DATE is the date of the lab assessment. 
a Rescue Phase only. HSCTSTDY = DATE – (Date of Day +0 post-VOD Treatment) + 1, where DATE is the date 
of the lab assessment. 
 
8.4.3 Vital Signs 
Intensive vital signs recorded during the first and second infusion of defibrotide on the first day 
of defibrotide dosing will be summarized at the nominal visit and time recorded in EDC. The 
analysis windows for all other visits will follow Table 1 and Table 2 in Section 8.4.1 for the 
prophylaxis and rescue phases, respectively.  
 
9 STUDY POPULATION SUMMARIES 
9.1 Enrollment 
The number of subjects in each analysis set will be tabulated overall and by treatment group with 
the exception of screened subjects, who will only be tabulated in the Total column. The ITT 
Analysis Set will be further summarized by randomization strata. Counts and percentages will be 
presented for each stratification level separately (High Risk, Very High Risk, Adult, and 
Pediatric) and for the 4 combinations of strata for risk status and age group across all countries 
and centers and separately by center within country.  
 
Additionally, summaries for public disclosure will tabulate subjects enrolled by country and site 
and by age category in the ITT Analysis Set.  
 
The following summaries will be provided: 
• Summary of analysis sets  
• Summary of randomized subjects by risk status, age group, country, and center within 
country  
• Number of subjects enrolled by country and site (for public disclosure) 
• Number of subjects enrolled by age category (for public disclosure) 
 
The following listings will be provided: 
• Listing of analysis sets 
o This listing will include a column header for each Analysis Set. Subjects will be 
flagged as “Yes” or “No” depending on whether or not they are included in each 
Analysis Set.  


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• Listing of informed consent and eligibility  
o This listing will include the date of informed consent/assent, the protocol version 
for consent/assent, and inclusion and exclusion criteria that were not met for all 
enrolled subjects.  
• Stratification at randomization  
o This listing will include each stratification factor of risk status, age group, and 
country collected in IRT at randomization.  
• Discrepancies in risk status between IRT and EDC  
o This listing will include subjects who had a discrepant risk status between EDC 
and IRT. Stratification at randomization was based on data entered in IRT at the 
time of randomization. If this status was later found to be incorrect it was not 
changed in IRT but the correct status was entered into EDC.  
• Reasons for Screen Failure 
o This listing will include the previous screening number (if applicable), screening 
date, and reason for screen failure for all subjects who failed screening and were 
not randomized.  
9.2 Disposition 
9.2.1 Subject Disposition 
A summary and listing of subject disposition, including study completion, study withdrawal, and 
reasons for study withdrawal, will be provided overall and by treatment group. Additionally, a 
disposition summary by study period for public disclosure will be provided in the ITT Analysis 
Set.  
 
The following summaries will be provided: 
• Summary of subject disposition 
• Study disposition by study period (for public disclosure) 
 
The following listing will be provided: 
• Subject disposition 
9.2.2 Study Treatment Disposition during Prophylaxis Phase 
A summary and listing of DP disposition including the number of subjects who received at least 
one dose of DP treatment, DP completion, DP discontinuation, and reasons for DP 
discontinuation will be provided for the DP arm using the ITT Analysis Set.  
 
The following summaries will be provided: 
• Summary of DP treatment disposition 
 
The following listing will be provided: 
• Listing of DP treatment disposition 


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9.2.3 Study Treatment Disposition during Rescue Phase 
A summary and listing of defibrotide rescue treatment disposition including the number of 
subjects who received at least one dose of defibrotide rescue treatment, defibrotide rescue 
treatment completion, defibrotide rescue treatment discontinuation, and reasons for defibrotide 
rescue treatment discontinuation will be provided overall and by treatment group using the ITT 
Analysis Set.  
 
The following summaries will be provided: 
• Summary of defibrotide rescue treatment disposition 
 
The following listing will be provided: 
• Listing of defibrotide rescue treatment disposition 
9.3 Protocol Deviations 
Protocol deviations are classified as major or minor in accordance with the Protocol Deviation 
Management Plan. Major protocol deviations will be summarized overall and by treatment group 
for the ITT Analysis Set. Subjects with more than one major protocol deviations will be counted 
only once in the total number of subjects with major protocol deviations.  
 
The following summaries will be provided: 
• Summary of major protocol deviations 
 
The following listing of all protocol deviations will be provided: 
• Listing of all protocol deviations 
o This listing will include deviation type, deviation category, date of deviation, a 
description, and whether it was major or minor.  
9.4 Demographics and Baseline Characteristics 
9.4.1 Demographics and Baseline Characteristics 
Subject demographics (gender, race, ethnicity, and age at screening) and baseline characteristics 
(weight, height, and body mass index [BMI]) will be summarized overall and by treatment group 
for the ITT Analysis Set and the Safety Analysis Set. Additionally, information pertaining to the 
underlying disease will be presented including primary disease, time since initial diagnosis, 
number of recurrences for the primary disease, whether it is a malignant disease, and prior 
treatment for the primary diagnosis (eg, surgery, radiation, chemotherapy, other). This summary 
will be repeated for the pediatric and adult subgroups. It will also be repeated by risk status (high 
risk and very high risk). Summaries by risk subgroups in the ITT Analysis Set will use the 
randomized risk status recorded in IRT, whereas summaries by risk status in the Safety Analysis 
Set will use the actual risk status recorded in EDC.  
The following summaries will be provided: 
• Demographic and baseline characteristics in the ITT Analysis Set 
• Demographic and baseline characteristics in the Safety Analysis Set 


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• Demographic and baseline characteristics for the pediatric subgroup in the ITT Analysis 
Set 
• Demographic and baseline characteristics for the pediatric subgroup in the Safety 
Analysis Set 
• Demographic and baseline characteristics for the adult subgroup in the ITT Analysis Set 
• Demographic and baseline characteristics for the adult subgroup in the Safety Analysis 
Set 
• Demographic and baseline characteristics for the high risk subgroup in the ITT Analysis 
Set 
• Demographic and baseline characteristics for the high risk subgroup in the Safety 
Analysis Set 
• Demographic and baseline characteristics for the very high risk subgroup in the ITT 
Analysis Set 
• Demographic and baseline characteristics for the very high risk subgroup in the Safety 
Analysis Set 
The following listing will be provided: 
• Demographic and baseline characteristics  
o This listing will include the demographic and baseline characteristics noted 
above. 
• Childbearing potential and pregnancy test results 
o This listing will contain childbearing potential status, the type of pregnancy test, 
and the results of the pregnancy test.  
• Disease history  
o This listing will include the information pertaining to underlying disease noted 
above. 
• Listing of risk factors for VOD 
o This listing will present high risk and very high risk factors for VOD collected on 
the eCRF. These are risk factors reported in EDC and were used in determining 
the risk category for safety analyses. 
• Liver history  
o This listing will present liver history information including history of active 
hepatitis, liver metastasis, and test data and result.  
9.4.2 Transplant Characteristics  
Transplant characteristics and information pertaining to HSCT including type of graft, source of 
graft, degree of human leukocyte antigen (HLA) matching, and type of conditioning regimen 
will be summarized overall and by treatment group using the ITT Analysis Set. These data will 
also be listed.  The type of conditioning regimen will be derived as follows: 
• Myeloablative 
o The type of conditioning regimen will be categorized as ‘Myeloablative’ if at least 
2 alkylating agents are reported on the conditioning regimen eCRF from this list: 
 Busulfan, cyclophosphamide, melphalan, bendamustine, carmustine, 
cisplatin, chlorambucil, carboplatin, oxaliplatin, thiotepa, lomustine, 
treosulfan 


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OR 
 
o if Total Body Irradiation (TBI) is reported on the conditioning regimen eCRF plus 
at least 1 alkylating agent from this list: 
 Busulfan, cyclophosphamide, melphalan, bendamustine, carmustine, 
cisplatin, chlorambucil, carboplatin, oxaliplatin, thiotepa, lomustine, 
treosulfan 
 
• Non-Myeloablative 
o If the conditioning regimen has not been categorized ‘Myeloablative’ as specified 
above, and if the type of conditioning regimen is recorded as ‘Non-myeloablative’ 
on the conditioning regimen eCRF, then the type will be categorized as ‘Non-
myeloablative’. 
 
• Reduced Intensity Chemistry (RIC) 
o If the conditioning regimen has not been categorized ‘Myeloablative’ or ‘Non-
myeloablative’ as specified above, and if the type of conditioning regimen is 
recorded as ‘Reduced Intensity Chemistry (RIC)’ on the conditioning regimen 
eCRF, then the type will be categorized as ‘Reduced Intensity Chemistry (RIC)’. 
 
• Other 
o If none of the above criteria are met, the type of conditioning regimen will be 
categorized as “Other.” 
 
The following summary will be provided: 
• Summary of transplant characteristics 
 
The following listing will be provided: 
• Listing of transplant characteristics 
9.4.3 Medical History  
Medical history will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 
version 19.1. A summary of medical conditions and surgical events by treatment group, system 
organ class (SOC), and preferred term (PT) will be provided for the ITT Analysis Set. SOC and 
PT within SOC will be sorted by frequency in the DP arm and then alphabetically for those with 
the same frequency. 
 
The following summary will be provided: 
• Summary of medical history  
 
The following listing of medical conditions and surgical events will be provided along with the 
start date, ongoing (Yes or No), and the end date, if not ongoing: 
• Listing of medical history   


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9.5 Prior and Concomitant Medications  
Prior and concomitant medications will be coded using the World Health Organization (WHO) 
Drug Dictionary and will be summarized by treatment group for the ITT Analysis Set. 
Summaries will show the number and percentage of subjects taking medications. Each subject is 
counted once within each unique term. Summaries will be sorted by descending frequency in the 
DP arm. 
 
Prior medications are defined as those medications taken prior to the Baseline date. Concomitant 
medications are defined as medications taken at any time on or after Baseline. If any medications 
were taken prior to Baseline and continued to be taken after Baseline, they will be counted as 
both prior and concomitant medications. The prior and concomitant categorization of 
medications will be derived after taking into consideration any partial or missing start and end 
dates as described in Sections 8.1.2.2 and 8.1.2.3.  
 
Information on conditioning regimen for HSCT is collected on the Conditioning Regimen eCRF 
and will be presented as a separate subset of concomitant medications. A summary of 
conditioning regimen for HSCT will be provided by treatment group for the ITT Analysis Set. 
 
The following summaries will be provided: 
• Summary of prior medications 
• Summary of concomitant medications 
• Summary of conditioning regimen for HSCT 
 
The following listings of medication will be provided along with the start date, ongoing (Yes or 
No), the end date if not ongoing, dose, unit, indication, frequency, and route: 
• Listing of prior medications 
• Listing of concomitant medications 
• Listing of conditioning regimen for HSCT 
 
Additionally, the following listing will be provided to include the date and reason for donor 
lymphocyte infusion: 
• Listing of donor lymphocyte infusion 
 
10 EFFICACY 
Although randomization is stratified by 3 variables, only 2 stratification variables (very high risk 
or high risk and pediatric [≤16 years] or adults [>16 years]) recorded in IRT will be used in the 
stratified tests described in this section (ie, the stratified log-rank test, the stratified Cox 
proportional hazards regression model and Cochran-Mantel-Haenszel [CMH] test) for the 
primary efficacy endpoint and the secondary efficacy endpoints, as appropriate. These 2 
stratification variables yield 4 distinct strata corresponding to unique levels of randomization 
strata. If there are fewer than 20 subjects in at least 1 of the 4 distinct strata, only the very high 
risk/high risk strata will be used in the stratified tests. Although the randomization will be 
stratified by country as well to ensure balance of treatment, due to the expected low enrollment 
within some countries, the stratified efficacy analyses will not be stratified by country. 
 


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Analyses and summaries using the ITT and mITT analysis sets will be stratified using data 
reported in the IRT system at the time of randomization. If the number of subjects with 
discrepancies between IRT and EDC with regard to stratum assignment is greater than or equal 
to 5% of the randomized subjects, the primary and key secondary efficacy endpoint analyses will 
be repeated using the stratum assignment reported in EDC as sensitivity analyses.  
10.1 
Analysis of Primary Endpoint 
The primary efficacy endpoint is VOD free survival by Day +30 post-HSCT. An event for the 
primary efficacy endpoint is defined as VOD diagnosis (as assessed by EPAC) or death, 
whichever is earlier, up to Day +30 post-HSCT. 
 
The time to event for the primary efficacy endpoint will be measured in days and will be 
calculated as described in Section 8.2.4 with the event date equal to the date of VOD diagnosis 
by EPAC, the date of death up to Day +30 post-HSCT, or the censoring date if no VOD or death 
occurred. 
 
Subjects will be censored under the following conditions: 
• No event by Day +30 post-HSCT:  
o If EPAC makes an assessment of ‘No VOD’ and the subject is still alive at Day 
+30 post-HSCT, the censoring date will be defined as earliest date of the last 
assessments available for the modified Seattle criteria components (total bilirubin, 
weight gain or ascites evaluation, hepatomegaly evaluation) or the last biopsy 
assessment, whichever is later. Only assessment dates occurring on or before 
Day+30 post-HSCT will be taken into consideration when censoring.  
o If the subject is still alive at Day +30 post-HSCT and has EPAC-assessed VOD 
after Day +30 post-HSCT, the censoring date will be Day +30 post-HSCT. 
• Not evaluable by Day +30 post-HSCT:  
o If the EPAC makes an assessment of ‘Not Evaluable’ and the subject has not died 
by Day +30 post-HSCT, the censoring date will be defined as the last date at 
which VOD could be evaluated (as specified by the EPAC).  
o If the EPAC indicates the last date at which VOD could be evaluated is prior to 
HSCT, the censoring date will be Day +1 post-HSCT. 
• Event occurs prior to HSCT: 
o If the EPAC indicates the date of VOD onset is prior to Day +0 post-HSCT or if 
the subject dies prior to Day +0 post-HSCT, the censoring date will be Day +1 
post-HSCT because the subject was not at risk at the start of the observation 
period. 
• Subject does not undergo HSCT:  
o The date of randomization will be used as Day +0 post-HSCT. The censoring date 
will be Day +1 post-HSCT.  
• Rescue treatment:  
o If a subject in the BSC arm receives rescue treatment with defibrotide but VOD 
(as assessed by investigator) is not confirmed by EPAC (either EPAC made an 
assessment of ‘No VOD’ or ‘Not Evaluable’ by Day +30 post-HSCT or the EPAC 


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made an assessment of VOD but the VOD date is more than 3 days later than the 
rescue initiation date), the subject will be censored at the date of rescue initiation. 
 
Subjects assessed for the primary efficacy endpoint before the interim analysis make up the stage 
1 sample and those subjects assessed after the interim analysis make up the stage 2 sample. At 
the interim analysis, a stratified log rank test will be performed where the strata are defined by 
risk status (high risk versus very high risk) and age group (pediatric vs. adult). If there are fewer 
than 20 subjects within a stratum, the stratified log rank test will be performed considering high 
risk versus very high risk strata only. The strata used in the stage 1 analysis will also be used to 
calculate the stratified log rank statistic for stage 2, regardless of the sizes of the strata observed 
in the stage 2 sample. For the final analysis, the method of Cui, Hung, and Wang (CHW) (Cui, 
Hung, & Wang, 1999) will be used to combine the independent increments of the stratified log 
rank statistics from stage 1 and stage 2. 
 
Let 𝑍𝑍1 and 𝑍𝑍2 denote the independent stratified log rank statistics (see, eg, Collett 2003) 
calculated based on the samples from stage 1 and stage 2, respectively. The stratified log rank 
statistics will be calculated with respect to events in the control group so that they have positive 
expectation under the alternative hypothesis. The final test statistic is 
 
𝑍𝑍𝐶𝐶𝐶𝐶𝐶𝐶= √𝑤𝑤 𝑍𝑍1 + √1 −𝑤𝑤 𝑍𝑍2 
 
where 𝑤𝑤= 0.7 = 252/360, the planned information fraction at the time of the interim analysis.  
 
The stage 1 stratified log rank statistic 𝑍𝑍1 = 𝑈𝑈1/ඥ𝑉𝑉1 is calculated based on log rank score 𝑈𝑈1 
with variance 𝑉𝑉1.  
 
 
Let 𝑡𝑡(1) < ⋯< 𝑡𝑡( 𝐽𝐽) be the ordered event times across the two treatment groups within stratum s.  
At time 𝑡𝑡( 𝑗𝑗) there are 𝑑𝑑𝑠𝑠𝑠𝑠 events in stratum s and just before time 𝑡𝑡( 𝑗𝑗) there are a total of  𝑟𝑟𝑠𝑠𝑠𝑠=
𝑟𝑟𝐶𝐶𝐶𝐶𝐶𝐶+ 𝑟𝑟𝐸𝐸𝐸𝐸𝐸𝐸 subjects at risk in stratum s, with 𝑟𝑟𝐶𝐶𝐶𝐶𝐶𝐶 subjects at risk in the control group (BSC) and 
𝑟𝑟𝐸𝐸𝐸𝐸𝐸𝐸 subjects at risk in the experimental group (DP) (Collett, 2003).  
 
In the stratified case, the log rank score is given as the sum of the scores calculated separately 
within each stratum: 
𝑈𝑈1 = ෍𝑂𝑂𝑠𝑠−𝐸𝐸𝑠𝑠
𝑆𝑆
𝑠𝑠=1
 
where 𝑂𝑂𝑠𝑠= ∑
𝑂𝑂𝑠𝑠𝑠𝑠
𝐽𝐽
𝑗𝑗=1
 is the total number of events in  the control group in stratum s, and 𝐸𝐸𝑠𝑠=
∑
𝐸𝐸𝑠𝑠𝑠𝑠
𝐽𝐽
𝑗𝑗=1
= ∑
൬
𝑟𝑟𝐶𝐶𝐶𝐶𝐶𝐶
𝑟𝑟𝑠𝑠𝑠𝑠൰𝑑𝑑𝑠𝑠𝑠𝑠
𝐽𝐽
𝑗𝑗=1
 is the total number of expected events in the control group in stratum 
s.  
 
Similarly, the variance of the score is given by the sum of the variances calculated separately 
within each stratum: 


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𝑉𝑉1 = ෍𝑉𝑉𝑠𝑠
𝑆𝑆
𝑠𝑠=1
 
 
where 𝑉𝑉𝑠𝑠= ∑
𝑟𝑟𝐶𝐶𝐶𝐶𝐶𝐶 𝑟𝑟𝐸𝐸𝐸𝐸𝐸𝐸 𝑑𝑑𝑠𝑠𝑠𝑠 (𝑟𝑟𝑠𝑠𝑠𝑠−𝑑𝑑𝑠𝑠𝑠𝑠)
𝑟𝑟𝑠𝑠𝑠𝑠
2 (𝑟𝑟𝑠𝑠𝑠𝑠−1)
𝐽𝐽
𝑗𝑗=1
  
 
The stage 2 stratified log rank statistic 𝑍𝑍2 = 𝑈𝑈2/ඥ𝑉𝑉2 is calculated based on log rank score 𝑈𝑈2 with 
variance 𝑉𝑉2.  
 
Under the null hypothesis of no difference in survival curves within each stratum, 𝑍𝑍1 and 𝑍𝑍2 have 
standard normal asymptotic distribution. Thus, at the interim analysis the p-value is calculated as 
follows: 
𝑝𝑝1 = 1 −Φ(𝑍𝑍1) 
Let 𝑐𝑐1 and 𝑐𝑐2 be the efficacy boundaries at the interim and final analysis times such that  
1 −Φ(𝑐𝑐1) = 0.0005 
or equivalently, 
𝑐𝑐1 = Φ−1(0.9995) = 3.2905 
And   
𝑃𝑃0(𝑍𝑍1 ≤𝑐𝑐1 𝑎𝑎𝑎𝑎𝑎𝑎 𝑍𝑍𝐶𝐶𝐶𝐶𝐶𝐶> 𝑐𝑐2) = 0.0245 
 
Using numerical integration one can solve this equation to get 𝑐𝑐2 = 1.9603. 
Let 
𝛼𝛼2 = 1 −Φ(𝑐𝑐2) = 0.02498 
 
The decision rule for declaring efficacy at the interim analysis is as follows: 
 
If 𝑝𝑝1 < 0.0005, 𝑜𝑜𝑜𝑜 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 𝑍𝑍1 > 𝑐𝑐1 , then reject 𝐻𝐻0 at the interim analysis and recommend 
stopping the trial early for overwhelming efficacy. 
 
The p-value at the final analysis is defined by 
 
𝑝𝑝𝐶𝐶𝐶𝐶𝐶𝐶= 1 −Φ(𝑍𝑍𝐶𝐶𝐶𝐶𝐶𝐶) 
 
The decision rule for declaring efficacy at the final analysis is: 
 
If 𝑝𝑝𝐶𝐶𝐻𝐻𝐻𝐻< 𝛼𝛼2  𝑜𝑜𝑜𝑜 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒  𝑍𝑍𝐶𝐶𝐶𝐶𝐶𝐶> 𝑐𝑐2 , then reject 𝐻𝐻0 and declare efficacy. 
 


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Cui, Hung, and Wang have shown that the type-1 error will be preserved at the specified 𝛼𝛼 level 
despite the possibility of a data dependent increase in the sample size. 
 
The primary analysis will be performed on the ITT Analysis Set as described above. The 
independent stratified log rank statistics from stage 1 (Z1) and stage 2 (Z2) will be presented 
along with ZCHW and the p-value (PCHW). In addition, the following descriptive statistics will be 
presented to support the analysis of the primary efficacy endpoint:  
 
o The number of subjects by treatment group who had an event and who were censored 
(either due to not having an event or for other reasons as described above). 
o The Kaplan-Meier (KM) estimates of the VOD-free survival rate (%) by Day +30 post-
HSCT (95% CI). 
o the KM estimate of median time to VOD or death in days (95% CI).  
o The HR (95% CI) from a Cox proportional hazards regression model stratified by risk 
status and age group. 
o A KM plot will be presented up to Day +180 post-HSCT for each treatment arm. The 
number of subjects at risk will be displayed at 10-day intervals. A vertical line will be 
included to indicate Day +30 post-HSCT. 
 
The following summary will be provided: 
• Analysis of VOD-free survival by Day +30 post-HSCT 
 
The following figure will be provided: 
• VOD-free survival by Day +30 post-HSCT (primary efficacy endpoint): KM Plot with 
number of subjects at risk 
 
The following listing will be provided and will include the EPAC diagnosis, rationale, VOD 
onset date, criteria met for diagnosis, and the last date VOD could be evaluated if the case was 
nonevaluable: 
• Listing of EPAC assessment of VOD  
 
10.1.1 Sensitivity Analyses of Primary Endpoint 
This section describes alternative analysis approaches to address missing data, as well as to 
explore modifications to the definition of the primary endpoint and analysis population. The 
additional analyses described in this section will serve as sensitivity analyses, to be used for 
qualitative evaluation of the robustness of the primary analysis methodology. The sensitivity 
analyses will be conducted using the same methods as the primary efficacy endpoint analysis 
described in Section 10.1 unless otherwise noted.  
 
10.1.1.1  Sensitivity Analysis I: Early Termination before Day +30 post-HSCT 
If a subject is terminated early (prior to the Day +180 post-HSCT visit as recorded on the end of 
study eCRF), lost to follow-up, or assessed as ‘Not Evaluable’ by EPAC before Day +30 post-
HSCT with the last assessment for evaluation of VOD less than Day +23 post-HSCT and this 
subject does not have VOD or death by Day +30 post-HSCT, a worst-case comparison will be 


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performed as a sensitivity analysis.  If in the DP arm, these subjects will be analyzed with an 
event on the day after the date of the last available assessment for the evaluation of VOD; if in 
the BSC arm, these subjects will be censored on the date of the last available assessment for the 
evaluation of VOD. The last available assessment for the evaluation of VOD is defined as the 
latter of the following 2 dates: 1) the last biopsy assessment date if a biopsy is done 2) the 
earliest date of the last assessments of the modified Seattle criteria components: bilirubin, weight 
gain or ascites evaluation, hepatomegaly evaluation. This worst-case comparison is a 
conservative method to evaluate the impact of missing data on the primary efficacy endpoint. 
 
The following summary will be provided: 
• Sensitivity analysis I: Analysis of VOD-free survival by Day +30 post-HSCT 
 
The following figure will be provided: 
• VOD-free survival by Day +30 post-HSCT (sensitivity analysis I): KM plot with number 
of subjects at risk 
 
10.1.1.2 Sensitivity Analysis II: CMH Test on the Composite Event Rate 
A composite event defined as a binary outcome where subjects who had either VOD (assessed 
by EPAC) or death by Day +30 post-HSCT will be considered to have an event. These events 
will be analyzed using a CMH test, stratified by the risk status (high risk vs very high risk) and 
age group (pediatric vs adult). If there are fewer than 20 subjects within a stratum, the CMH test 
will be performed considering high risk versus very high risk strata only.  
 
The following summary will be provided: 
• Sensitivity analysis II: Analysis of VOD-free survival by Day +30 post-HSCT 
 
10.1.1.3 Sensitivity Analysis III: Unstratified Log Rank Test 
The primary endpoint of VOD-free survival by Day +30 post-HSCT will be analyzed using a log 
rank test, without consideration of the stratification factors. This analysis is a simple comparison 
to the stratified analysis specified as the main analysis, and is expected to be less powerful.  
 
The following summary and figure will be provided: 
• Sensitivity analysis III: Analysis of VOD-free survival by Day +30 post-HSCT 
 
The following figure will be provided: 
• VOD-free survival by Day +30 post-HSCT (sensitivity analysis III): KM plot with 
number of subjects at risk 
 
10.1.1.4  Sensitivity Analysis IV: Stratified Log Rank Test in the mITT Analysis Set 
The primary efficacy analysis of VOD-free survival by Day +30 post-HSCT will be repeated for  
the mITT Analysis Set.  
 


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The following summary will be provided: 
• Sensitivity analysis IV: Analysis of VOD-free survival by Day +30 post-HSCT 
 
The following figure will be provided: 
• VOD-free survival by Day +30 post-HSCT (sensitivity analysis IV): KM plot with 
number of subjects at risk 
 
10.1.1.5  Sensitivity Analysis V: Log Rank Test on VOD-free Survival by Day +30 post-
HSCT (with EPAC Assessment Only) 
In all of the previously described analyses, if a subject in the BSC arm is rescued but VOD 
(assessed by investigator) is not confirmed by the EPAC (either the EPAC made an assessment 
of No VOD by Day +30 post-HSCT, or the EPAC made an assessment of VOD but the VOD 
date is more than 3 days later than the rescue initiation date), the subject will be censored at the 
time of rescue initiation. In this sensitivity analysis, such a consideration is dismissed. A 
subject’s VOD diagnosis by Day +30 post-HSCT status on will be based on the EPAC 
assessment only, without consideration of the administration of rescue defibrotide.  
 
The following summary will be provided: 
• Sensitivity analysis V: Analysis of VOD-free survival by Day +30 post-HSCT 
 
The following figure will be provided: 
• VOD-free survival by Day +30 post-HSCT (sensitivity analysis V): KM plot with 
number of subjects at risk 
 
10.1.2 Subgroup Analyses of Primary Endpoint 
The primary efficacy endpoint will be analyzed for each combination of the subgroups from the 
2 stratification variables (very high risk/high risk and pediatric [≤16 years]/adults [>16 years]). 
For each of the subgroups, the analysis will be conducted using the same methods as the primary 
efficacy endpoint analysis described in Section 10.1, except that the log rank test will be un-
stratified and no hypothesis testing will be performed.  
 
An additional subgroup analysis will be performed by prior liver disease status. Subjects are 
considered to have prior liver disease if they have at least one of the following criteria checked 
off on the ‘Risk Factors for VOD’ eCRF: 
o Transaminase level >2.5 times the upper limit of normal (ULN) during screening 
period 
o Serum total bilirubin level >1.5 times the ULN during screening period 
o Cirrhosis (with biopsy evidence) 
o Hepatic fibrosis (by histology) 
o Known history of active viral hepatitis within 1 year prior to the start of study 
treatment 
o Any prior hepatic irradiation, including abdominal irradiation covering the hepatic 
area 


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o Documented diagnosis of iron overload (serum ferritin > 2000 ng/mL within 
3 months prior to start of study treatment) 
 
The following summaries will be provided: 
• Analysis of VOD-free survival by Day +30 post-HSCT by age group 
• Analysis of VOD-free survival by Day +30 post-HSCT by risk status 
• Analysis of VOD-free survival by Day +30 post-HSCT by age group and risk status 
• Analysis of VOD-free survival by Day +30 post-HSCT by prior liver disease status 
 
The following figures will be provided: 
• Figure of VOD-free survival by Day +30 post-HSCT by age group 
• Figure of VOD-free survival by Day +30 post-HSCT by risk status 
• Figure of VOD-free survival by Day +30 post-HSCT by age group and risk status 
• Figure of VOD-free survival by Day +30 post-HSCT by prior liver disease status 
 
10.1.3 Concordance between Investigator and EPAC Assessed VOD by Day +30 post-
HSCT 
The investigator-assessed VOD by Day +30 post-HSCT will be derived from the clinical 
database, whereas the EPAC assessed VOD by Day +30 post-HSCT will be extracted from the 
EPAC assessment forms. Investigator assessments will be binary (‘yes’ or ‘no’). The EPAC can 
assess a case as ‘yes’, ‘no’, or ‘not evaluable’. All combinations of investigator and EPAC 
assessments will be tabulated for the mITT Population by treatment group and by site and 
treatment group (ie, ‘yes/yes’, ‘yes/no’, ‘no/no’, ‘no/yes’, ‘yes/not evaluable’, ‘no/not 
evaluable’). A concordant assessment is defined as the following: the outcome of VOD by Day 
+30 post-HSCT matches between investigator and EPAC assessments (ie, ‘yes/yes’ or ‘no/no’).  
 
For cases where both the investigator and EPAC assessed VOD by Day +30 post-HSCT (ie, 
‘yes’, ‘yes’), the dates of VOD diagnosis will be compared to determine if they match between 
the two assessments. A case will be considered concordant if the dates of diagnosis match. The 
number of concordant and discordant cases will be tabulated by treatment group and by site and 
treatment group. 
 
A descriptive analysis of investigator-assessed VOD-free survival by Day +30 post-HSCT will 
be conducted using the same methods as the primary efficacy endpoint analysis described in 
Section 10.1. No hypothesis testing will be performed. 
 
The following summaries will be provided: 
• Concordance between PI and EPAC assessed VOD by Day +30 post-HSCT 
• Concordance between PI and EPAC assessed VOD by Day +30 post-HSCT by site 
• Analysis of investigator-assessed VOD-free Survival by Day +30 post-HSCT 
 
The following listing will be provided and will include VOD diagnosis, date of diagnosis, criteria 
met, and biopsy results: 
• Listing of investigator-assessed VOD 


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The following figure will be provided: 
• Investigator-assessed VOD-free survival by Day +30 post-HSCT: KM plot with number 
of subjects at risk 
 
10.2 
Analysis of Secondary Endpoints 
10.2.1 Key Secondary Efficacy Endpoint 
The key secondary efficacy endpoint is VOD-free survival by Day +100 post-HSCT and will be 
analyzed using the same methods described in Section 10.1 for the primary efficacy endpoint in 
the ITT Analysis Set.  
 
The following summary will be provided: 
• Analysis of VOD-free survival by Day +100 post-HSCT 
 
The following figure will be provided: 
• Figure of VOD-free survival by Day +100 post-HSCT 
 
10.2.2 Other Secondary Efficacy Endpoints 
These other secondary efficacy endpoints will be tested without multiplicity adjustments, and 
nominal p-values will be reported.  The ITT Analysis Set will be used for these analyses. 
 
10.2.2.1  Incidence of VOD by Day +30 post-HSCT 
The incidence of EPAC-assessed VOD by Day +30 post-HSCT will be compared between 
treatment arms using the CMH test stratified by 2 stratification variables for randomization (very 
high risk/high risk and pediatric/adults). 
 
The following summary will be provided: 
• 
Incidence of VOD by Day +30 post-HSCT 
 
10.2.2.2  VOD-Free Survival by Day +180 post-HSCT 
The secondary efficacy endpoint of VOD-free survival by Day +180 post-HSCT will be 
analyzed using the methods described in Section 10.1 in the ITT Analysis Set. For monitoring of 
VOD-free survival by Day +180 post-HSCT, the diagnosis of VOD through Day +100 post-
HSCT will be made by EPAC, and the diagnosis of VOD after Day +100 post-HSCT will be 
based on investigator assessments. 
 
The following summary will be provided: 
• Analysis of VOD-free survival by Day +180 post-HSCT 
 


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The following figure will be provided: 
• Figure of VOD-free survival by Day +180 post-HSCT 
 
10.2.2.3  Non-Relapse Mortality by Days +100 and +180 post-HSCT 
The incidence of NRM by Day +100 post-HSCT will be compared between the treatment arms. 
NRM is defined as death that occurs after HSCT in subjects who were noted as having malignant 
primary disease on the disease history eCRF and who do not have primary disease relapse post-
HSCT. Only subjects with malignant primary disease at baseline will be included in the analysis. 
The time to NRM is the number of days from the date of Day +0 post-HSCT to the date of NRM. 
If the subject has disease relapse, they will be censored on the date of relapse. If they do not have 
disease relapse and do not die by Day +100 post-HSCT then will be censored on the date of the 
Day +100 post-HSCT disease relapse assessment. If the Day +100 post-HSCT disease relapse 
assessment is missing, they will be censored on the date of the last disease relapse assessment 
performed. If a subject does not undergo HSCT, the subject will be censored at the date of Day 
+1 post-HSCT. 
 
This analysis will be repeated for NRM by Day +180 post-HSCT. The following will be 
presented for NRM by Day +100 post-HSCT and by Day +180 post-HSCT: 
o The number of subjects by treatment group who had an event and who were censored 
(either due to not having an event or for other reasons as described above). 
o The p-value from a log rank test stratified by risk status and age group. 
o The KM estimates of the NRM rate (%) with 95% CI. 
o the KM estimate of median time to NRM in days (95% CI).  
o The hazard ratio (95% CI) from a Cox proportional hazards regression model stratified 
by risk status and age group. 
o A KM plot will be presented up to Day +180 post-HSCT for each treatment arm. The 
number of subjects at risk will be displayed at 10-day intervals.  
 
The following summary will be provided: 
• Analysis of non-relapse mortality post-HSCT 
 
The following figure will be provided: 
• Figure of non-relapse mortality post-HSCT 
 
The following listing will be provided and will include the relapse status at each visit and the 
date of relapse if applicable: 
• Listing of primary disease relapse  
 
10.2.2.4  Incidence of VOD-associated MOD by Days +30 and +100 post-HSCT 
VOD-associated MOD is defined for subjects as occurring if the investigator answers “Yes” to 
the question “Has the subject been diagnosed with VOD associated MOD?” in the eCRF. The 
number and proportion of subjects who develop VOD-associated MOD by Days +30 and +100 
post-HSCT will be summarized and compared between the 2 treatment arms using a chi-square 
test. 


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The following summary will be provided: 
• Summary of VOD-associated MOD  
 
The following listing will be provided and will include the date of MOD and type of renal and 
pulmonary dysfunction: 
• Listing of VOD-associated MOD 
 
10.2.2.5  Resolution of VOD by Day +180 post-HSCT and Time to Resolution of VOD 
Of those subjects who were diagnosed with VOD by Day +30 post-HSCT by the investigator, 
the proportion of subjects who have resolution of VOD by Day +180 post-HSCT will be 
summarized by treatment arm.  
 
Time to resolution of VOD will be calculated as follows:  
 
Time to resolution of VOD = [Date of VOD resolution] – [Date of VOD diagnosis by 
investigator] 
 
If VOD does not resolve by Day +180 post-HSCT, the subject will be censored on the date of the 
Day +180 post-HSCT VOD resolution assessment. If the Day +180 post-HSCT VOD resolution 
assessment is missing, they will be censored on the date of the last VOD resolution assessment 
performed.  
 
The following will be presented for VOD resolution by Day +180 post-HSCT: 
o The number of subjects by treatment group who had an event and who were censored 
(either due to not having an event or for other reasons as described above). 
o The p-value from a log rank test stratified by risk status and age group. 
o The KM estimates of the NRM rate (%) with 95% CI. 
o the KM estimate of median time to NRM in days (95% CI).  
o The HR (95% CI) from a Cox proportional hazards regression model stratified by risk 
status and age group. 
o A KM plot will be presented up to Day +180 post-HSCT for each treatment arm. The 
number of subjects at risk will be displayed at 10-day intervals.  
 
The following summary will be provided: 
• Analysis of VOD resolution by Day +180 post-HSCT 
 
The following figure will be provided: 
• Figure of VOD resolution by Day +180 post-HSCT 
 
The following listing will be provided and will include whether or not VOD was resolved, the 
criteria met for resolution, and the date of resolution: 
• Listing of VOD resolution 
 


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10.2.2.6  Incidence of VOD by Day +100 post-HSCT and Day +180 post-HSCT 
The number and proportion of subjects who develop VOD after Day +30 post-HSCT but by Day 
+100 post-HSCT and by Day +180 post-HSCT will be summarized and compared between the 
treatment arms using a chi-square test at each timepoint. The diagnosis of VOD through Day 
+100 post-HSCT will be made by EPAC, and the diagnosis of VOD after Day +100 post-HSCT 
will be based on investigator assessments. 
 
The following summary will be provided: 
• Incidence of VOD by Day +100 post-HSCT and Day +180 post-HSCT in subjects who 
develop VOD after Day +30 
 
11 SAFETY 
Safety summaries will be provided by treatment arm and study phase based on the Safety 
Analysis Set. 
11.1 
Extent of Exposure  
Defibrotide administration will be summarized for the Prophylaxis and Rescue Treatment 
phases. The following will be summarized and listed: 
o Days of study drug treatment: The number of days the subject received at least one 
dose of study drug treatment.  
o Duration of study drug treatment in days: (date of last dose – date of first dose) +1 
o The total number of doses received  
o The number of doses per day: Total number of doses received divided by the duration 
of study drug treatment. 
o Total exposure (mg): Total amount of study drug received by the subject in mg. 
o The daily dose in mg/day: Total exposure divided by the duration of treatment.  
o The daily dose in mg/kg/day: Total exposure divided by the duration of study drug 
treatment in days, and then divided by Baseline weight in kg.  
 
The following summary will be provided: 
• Summary of defibrotide administration   
 
The following listing will be provided: 
• Listing of defibrotide administration  
• List of subjects receiving test drug from specific batches  
 
11.2 
Adverse Events 
Adverse events recorded in the case report form will be coded to SOC and PT using the 
MedDRA 19.1. The investigator will assess the relatedness of each AE to study drug.  The 
severity of AEs will be recorded using the Common Terminology Criteria for Adverse Events 
(CTCAE 4.03).  


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At a minimum, for subjects in either the DP or BSC arm, the investigator must record all AEs 
and SAEs that occur from the time written informed consent is obtained until screen failure if 
applicable, or Day +60 post-HSCT, regardless of their relationship to study drug or procedure. 
Even if the minimum of Day +60 post-HSCT is met, the investigator must continue to record all 
AEs and SAEs that occur within 30 days after the last dose of defibrotide, regardless of their 
relationship to study drug or procedure. For subjects who do not receive HSCT, AEs must be 
collected for 70 days after Baseline or early termination, whichever occurs first. For subjects 
randomized but not treated, AEs will be collected for 70 days after randomization or early 
termination, whichever is earlier. Any SAE assessed as related to defibrotide or study procedures 
by the investigator should be reported regardless of time after study termination.  
Related SAEs reported after study termination will be collected in the Safety database only.  
A treatment-emergent adverse event (TEAE) is defined as any event with onset date on or after 
the first dose of study treatment (either DP or conditioning regimen) or any ongoing event that 
worsens in severity after the date of the first dose of study treatment through the protocol-
specific reporting period. Only TEAEs with the onset date on or before the end of the protocol-
specific AE reporting period noted above will be included in summary tables unless otherwise 
specified. All AEs will be listed. For the purpose of calculating treatment emergence, incomplete 
onset dates will be imputed as detailed in Section 8.1.2.1. 
AEs are graded by the investigator as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), 
Grade 4 (life threatening), or Grade 5 (fatal). The severity grade of events for which the 
investigator did not record severity will be categorized as “missing” for tabular summaries and 
data listings, and will be considered the least severe for the purposes of sorting for data 
presentation. 
Treatment-related AEs are those for which the investigator answers “Yes” to the question “Was 
this adverse event related to study treatment?” in the eCRF. Events for which the investigator did 
not record relationship to study treatment will be considered related to study treatment in 
summaries if the subject received defibrotide. They will be considered not related if the subject 
did not receive defibrotide. Data listings will show treatment relationship as missing.  
Serious AEs are those for which the investigator answers “Yes” to the question “Was the adverse 
event serious?” in the eCRF. The clinical database will be reconciled with the serious AE 
database before database finalization.  
For all AE summaries, if a subject has more than 1 AE within a PT, the subject is counted only 
once at the maximum severity and with the closest relationship to study drug. If a subject has 
more than 1 AE within a SOC, the subject is similarly counted once when reporting results for 
that SOC. SOC and PT will be sorted by frequency in the DP arm and then alphabetically for 
those with the same frequency. 
The following summaries will be provided (all summaries except the overall summary will be 
presented by SOC and PT within SOC): 
• Overall summary of TEAE 


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• Summary of TEAE by SOC and PT 
• Summary of TEAE by PT 
• Summary of TEAE by age group 
• Summary of serious TEAE 
• Summary of treatment-related TEAE 
• Summary of serious treatment-related TEAE 
• Summary of Grade 3 or 4 TEAE 
• Summary of treatment-related Grade 3 or 4 TEAE 
• Summary of TEAE leading to study drug discontinuation 
• Summary of treatment-related TEAE leading to study drug discontinuation 
• Summary of TEAE by maximum toxicity grade 
• Summary of treatment-related TEAE by maximum toxicity grade 
• Summary of TEAE leading to death 
• Summary of treatment-related TEAE leading to death 
• Summary of TEAE by SOC and PT including events recorded outside of the protocol-
specific AE reporting period  
o Some sites continued to record AEs beyond the protocol-defined reporting period. 
This table will summarize all AEs with onset date on or after the first dose of 
study treatment (either DP or conditioning regimen) through the end of the study. 
 
Additionally, the following TEAE summaries for public disclosure will be provided: 
• Summary of treatment-emergent serious AEs (for public disclosure) 
• Summary of treatment-emergent non-serious AEs occurring in greater than 5% of 
subjects (for public disclosure) 
 
The following listings will be provided along with subject number, treatment arm, verbatim term, 
SOC, PT, start date, end date, treatment-emergent flag, severity grade, seriousness, relationship 
to defibrotide, relationship to a study procedure, action taken, and outcome of the AE: 
• Listing of all AEs 
• Listing of SAEs 
• Listing of Grade 3 and 4 AEs 
• Listing of AEs leading to study drug discontinuation 
• Listing of AEs leading to death 
 
11.2.1 Adverse Events of Special Interest 
AEs of special interest include pulmonary hemorrhage, gastrointestinal bleeding, and 
hypersensitivity reactions. The list of PTs used to search for AEs of special interest is provided 
in Appendix I and was reviewed by Jazz Drug Safety & Pharmacovigilance and an independent 
DMC.  
 
The following summaries will be provided: 
• Summary of TEAEs of special interest: Pulmonary hemorrhage 


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• Summary of TEAEs of special interest: Pulmonary hemorrhage by age group 
• Summary of TEAEs of special interest: Gastrointestinal bleeding  
• Summary of TEAEs of special interest: Gastrointestinal bleeding by age group 
• Summary of TEAEs of special interest: Gastrointestinal bleeding likely pre-existing 
neurological or neonatal conditions 
• Summary of TEAEs of special interest: Gastrointestinal bleeding likely pre-existing 
neurological or neonatal conditions by age group 
• Summary of TEAEs of special interest: Hypersensitivity reactions 
• Summary of TEAEs of special interest: Hypersensitivity reactions by age group  
 
The following listings will be provided: 
• Listing of AEs of special interest: Pulmonary hemorrhage 
• Listing of AEs of special interest: Gastrointestinal bleeding 
• Listing of AEs of special interest: Gastrointestinal bleeding likely pre-existing 
neurological or neonatal conditions 
• Listing of AEs of special interest: Hypersensitivity reactions 
 
11.3 
Laboratory Assessments 
For all hematology, coagulation, and chemistry parameters, the lab values at baseline and each of 
the postbaseline assessments will be summarized and presented using descriptive statistics. See 
Section 8.4.1 for the identification of the assessments used in the analyses. For each of the 
postbaseline assessments, change between baseline and that assessment in a specific lab value 
will be calculated as follows, 
Change from baseline = [Lab value at the post-baseline assessment] – [Lab value at baseline], 
and will be summarized and presented using descriptive statistics. If the lab value is missing at 
either baseline or a specific post-baseline assessment for a subject, change from baseline will be 
missing.  
• Summary of clinical laboratory results: Hematology 
• Summary of clinical laboratory results: Chemistry 
• Summary of clinical laboratory results: Coagulation 
 
For each of the following select laboratory parameters: total bilirubin, serum creatinine, absolute 
neutrophil count, and platelet count, a shift table from baseline grade to the highest postbaseline 
grade will be provided: 
• Shift table of selected postbaseline laboratory results from baseline 
 
All laboratory results will be listed. In addition, a listing of subjects who have abnormal 
postbaseline lab values for select lab parameters (total bilirubin, serum creatinine, absolute 
neutrophil count, and platelet count) will be provided with corresponding normal ranges. The 
following listings will be provided: 
• Listing of clinical laboratory results: Hematology 
• Listing of clinical laboratory results: Chemistry 
• Listing of clinical laboratory results: Coagulation 


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• Listing of subjects with abnormal post-baseline laboratory values 
 
11.4 
Vital Signs 
Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and body 
temperature at baseline and each of the post-baseline assessments will be summarized and 
presented using descriptive statistics. See Section 8.4.3 for the identification of the assessments 
used in the analyses. For each of the post-baseline assessments, change between baseline and that 
assessment in a specific vital sign will be calculated as follows, 
 
Change from baseline = [Vital sign at the post-baseline assessment] – [Vital sign at baseline], 
 
and will be summarized and presented using descriptive statistics. If a specific type of vital signs 
is missing at either baseline or a specific post-baseline assessment for a subject, change from 
baseline will be missing.  
 
Maximum decrease and increase from baseline in systolic and diastolic blood pressure will be 
summarized separately using descriptive statistics, to assess the potential for defibrotide to cause 
peri-infusional hypotension.  
 
Baseline and post-baseline values for each visit in Section 8.4.3 will be categorized as low, 
normal, or high and presented on a shift table based on the criteria listed in Table 4.   
 
Table 4 – Vital Signs Normal Ranges 
Parameter 
Low 
Normal 
High 
Systolic blood pressure 
< 60 mmHg 
≥60 and ≤160 
mmHg 
>160 mmHg 
Diastolic blood pressure 
<50 mmHg 
≥50 and ≤100 
mmHg 
>100 mmHg 
Pulse rate 
<40 beats per min. 
≥40 and ≤120 beats 
per min. 
>120 beats per min. 
Respiratory rate 
<10 breaths per min. 
≥10 and ≤40 breaths 
per min. 
>40 breaths per min. 
Temperature 
<36 degrees 
Centigrade 
≥36 and ≤39 degrees 
Centigrade 
>39 degrees 
Centigrade 
 
The following summaries will be provided: 
• Summary of vital signs  
• Summary of maximum decrease and increase from baseline in systolic and diastolic 
blood pressure 
• Shift table of vital signs results from baseline 
 
The following listings will be provided: 
• Listing of vital signs 


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11.5 
Graft-versus-Host Disease 
The proportion of subjects who develop chronic GvHD by Day +180 post-HSCT will be 
summarized.  
 
The proportion of subjects with Grade 1, 2, 3, 4, 2-4, and 1-4 acute GvHD by Days +30, +100 
and +180 post-HSCT will be summarized. Acute GvHD (defined separately for subjects ≥ 45 kg 
or < 45 kg) is defined using stages and grades according to Jacobsohn and Vogelsang (Jacobsohn 
and Vogelsang 2007), as shown in Table 5.  
 
The following summary will be provided: 
• Summary of GvHD 
 
The following listings will be provided: 
• Listing of acute GvHD 
• Listing of chronic GvHD 
 
Table 5. Staging and Grading of Acute Graft versus Host Disease 
 
 
Skin 
Liver 
Gut 
 
 
Total bilirubin 
(mg/dL) 
Stool output  
(mL/day) 
Stage 
0 
No GvHD rash 
<2 
<500 or persistent nausea 
1 
Maculopapular rash <25% 
BSA 
2-3 
500-999 
or 
10-20 mL/kg/day for subjects <45 kg 
2 
Maculopapular rash 25%-
50% BSA 
3.1-6 
1000-1500  
or 
>20-35 mL/kg/day for subjects <45 kg 
3 
Maculopapular rash >50% 
BSA 
6.1-15 
>1500 
or 
>35 mL/kg/day for subjects <45 kg 
4 
Generalized erythroderma 
plus bullous formation 
>15 
Severe abdominal pain with or without ileus 
Grade 
Skin 
Liver 
Gut 
I 
Stage 1-2 
None 
None 
II 
Stage 3 or 
Stage 1 or 
Stage 1 
III 
— 
Stage 2-3 or 
Stage 2-4 
IV 
Stage 4 or 
Stage 4 
— 
GvHD: Graft-versus-host disease; BSA: Body surface area. 
Source: Jacobsohn & Vogelsang 2007 
 
11.6 
Graft Failure and Time to Neutrophil and Platelet Engraftment 
The incidence of neutrophil engraftment will be compared between the treatment arms. The date 
of neutrophil engraftment will be recorded on the eCRF and is defined as the first date after 
HSCT of an absolute neutrophil count > 0.5 × 109/L that is maintained for 3 consecutive days. 


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The definition of “absolute neutrophil count” includes both segmented neutrophils and “bands,” 
immature neutrophils. 
 
The time to neutrophil engraftment is the number of days from the date of Day +0 post-HSCT to 
the date of neutrophil engraftment. Subjects with engraftment failure will be censored at the date 
of last contact or the Day+180 post-HSCT assessment date whichever is earlier. Subjects with 
‘Never Below’ status will be censored at Day+1 post-HSCT. The remainder of the subjects who 
have not been considered as Engraftment/Failure/Never Below will be considered as 
‘Undetermined’ and censored at the last neutrophil engraftment assessment date. For these 
undetermined subjects who have no assessment date or if the assessment date is prior to or on the 
HSCT date, they will be censored at Day+1 post-HSCT. If a subject does not undergo HSCT, the 
subject will be censored at the date of Day +1 post-HSCT. 
 
This analysis will be repeated for platelet engraftment. The date of platelet engraftment will be 
recorded on the eCRF and is defined as the first date after HSCT of a platelet count > 20 × 109/L 
without a platelet transfusion in the preceding 7 days.  
 
The following will be presented for neutrophil engraftment and platelet engraftment: 
o The number of subjects by treatment group who achieved engraftment by Day +30 
post-HSCT, Day +100 post-HSCT, and Day +180 post-HSCT.  
o The number of subjects who were censored. 
o The number of subjects who were ‘Never Below’. 
o The number of subjects who did not have HSCT. 
o The KM estimates of the engraftment rate (%) at Day +100 post-HSCT (95% CI). 
o The KM estimate of median time to engraftment in days (95% CI).  
o A KM plot will be presented up to Day +180 post-HSCT for each treatment arm. The 
number of subjects at risk will be displayed at 10-day intervals.  
 
The following summaries will be provided: 
• Analysis of time to neutrophil engraftment 
• Analysis of time to platelet engraftment 
• Summary of graft failure 
 
The following figures will be provided: 
• Figure of neutrophil engraftment 
• Figure of platelet engraftment 
 
The following listings will be provided displaying the dates for engraftment or graft failure: 
• Listing of neutrophil and platelet engraftment 
• Listing of engraftment status 
11.7 
Karnofsky and Lansky Performance Scores 
For Karnofsky and Lansky performance scores, descriptive statistics as well as changes from 
baseline will be summarized and listed for each visit in Section 8.4.2. For each of the 
postbaseline assessments, change between baseline and that assessment will be calculated as 
follows: 


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Change from baseline = [post-baseline assessment date] – [baseline assessment date] 
 
and will be summarized and presented using descriptive statistics. If the performance score is 
missing at either baseline or a specific postbaseline assessment for a subject, change from 
baseline will be missing. 
 
The following summary will be provided: 
• Summary of Karnofsky and Lansky performance scores  
 
The following listing will be provided: 
• Listing of Karnofsky and Lansky performance scores 
 
11.8 
Abdominal Ultrasound 
Abdominal ultrasound assessments will be presented in the following listing and will include the 
date, liver size, presence of hepatomegaly, presence of ascites, and reversal of portal venous 
flow: 
• Listing of abdominal ultrasound  
 
12 HOSPITAL RESOURCE UTILIZATION 
Hospital resource utilization will be summarized by treatment arm for the Safety Analysis Set.  
 
The duration of hospital stay in days will be calculated as follows: 
 
Days in hospital = [Date of hospital discharge] – [Date of hospital admission] + 1 
 
If hospital re-admission occurs during the study, the duration of each re-admission will be 
calculated as noted above and the number of days in the hospital across all admissions will be 
summed to obtain the total duration of the hospital stay for each subject. If the date of hospital 
admission is prior to the date of informed consent, the informed consent date will be used as the 
date of admission. If the subject is still in the hospital at the time of study completion, death, or 
early termination, the discharge date will be recorded as “Not Applicable” on the eCRF and the 
date of study completion/early termination/death will be used as the discharge date. The total 
duration of the hospital stay will be summarized. The number of subjects who were hospitalized 
prior to informed consent and the number who were still hospitalized at the end of study 
participation will be tabulated.  
 
The total number of days in Intensive Care Unit (ICU) will be calculated using the same method 
noted above and summarized.   
 
Inpatient resource use and/or use of diagnostic tests during the initial hospital stay or during any 
re-admissions will be summarized and listed including the following: 
o Number of blood transfusions 


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o Total number of units for all transfusions received 
o Total number of days of ventilator use 
o Type of dialysis 
o Total number of days on dialysis 
o Number of liver biopsies 
o Number of bone marrow biopsies 
o Number of other biopsies 
 
The following summary will be provided: 
• Summary of hospital stay and resource utilization 
 
The following listings will be provided: 
• Listing of hospital and ICU stay  
• Listing of inpatient resource utilization 
 
13 HEALTH-RELATED QUALITY OF LIFE 
Health-related quality of life results will be summarized by treatment arm for the Safety Analysis 
Set.  
13.1 
EQ-5D-5L 
13.1.1 EQ-5D-5L Dimension 
For each of the 5 dimensions of mobility, self-care, activity, pain, and anxiety based on the 
descriptive system of the EQ-5D-5L, the numbers and percentages of subjects for all categories 
(the five levels of reported problems and question not completed) at baseline and each of the 
post-HSCT assessments will be presented. For each of the post-HSCT assessments, change 
between baseline and that assessment in each dimension will be categorized as follows for a 
specific subject: 
o Condition improved, if the reported level of problem is lower at that assessment than 
at baseline 
o Condition unchanged, if the reported level of problem remains the same 
o Condition deteriorated, if the reported level of problem is higher at that assessment 
than at baseline 
o Unknown, if the reported level of problem is missing either at baseline or at that 
assessment 
 
The numbers and percentages of subjects for all the above-mentioned categories will be 
presented for each dimension at each of the post-HSCT assessments.  
 
The following summaries will be provided: 
• Summary of EQ-5D-5L dimensions for adult subjects (age ≥16 years) by assessment 
• Summary of change in EQ-5D-5L dimensions from baseline for adult subjects (age ≥16 
years) by assessment 
 


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The following listing will be provided including results for each of the 5 dimensions and the 
visual analogue scale (VAS) score: 
• Listing of EQ-5D-5L 
13.1.2 EQ VAS Score 
The EQ VAS score at baseline and each of the post-HSCT assessments will be summarized and 
presented using descriptive statistics. A higher EQ VAS score represents better QoL. For each of 
the post-HSCT assessments, change between baseline and that assessment in the EQ VAS score 
will be calculated and will be summarized and presented using descriptive statistics.  
 
Change in the EQ VAS = [EQ VAS at the post-HSCT assessment] – [EQ VAS at baseline] 
 
The following summary will be provided: 
• Summary of EQ-5D-5L VAS score for adult subjects (age ≥16 years)  
 
13.2 
EQ-5D-Y 
13.2.1 EQ-5D-Y Dimension 
For each of the 5 dimensions based on the descriptive system of the EQ-5D-Y, self-report 
version, the numbers and percentages of subjects for all categories (the 3 levels of reported 
problems and question not completed) at baseline and each of the post-HSCT assessments will 
be presented. For each subject at a specific post-HSCT assessment, change between baseline and 
that assessment in each dimension will be categorized similarly to the change in each of the five 
dimensions in EQ-5D-5L (Section 13.1.1). The numbers and percentages of subjects for all 
categories in change between baseline and each of the post-HSCT assessments will be presented 
for each dimension.  
 
The following summaries will be provided: 
• Summary of EQ-5D-Y dimensions for pediatric subjects (age ≥8 and ≤15 years) by 
assessment 
• Summary of change in EQ-5D-Y dimensions from baseline for pediatric subjects (age ≥8 
and ≤15 years) by assessment 
•  
The following listing will be provided and will include results for each of the 5 dimensions and 
the VAS score: 
• Listing of EQ-5D-Y 
13.2.2 EQ VAS Score 
The EQ VAS score at baseline and each of the post-HSCT assessments will be summarized and 
presented using descriptive statistics. For each of the post-HSCT assessments, change between 
baseline and that assessment in the EQ VAS score will be calculated as mentioned in Section 
13.1.2 for a specified subject, and will be summarized and presented using descriptive statistics.  
 
The following summary will be provided: 


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• Summary of EQ VAS score for pediatric subjects (age ≥8 and ≤15 years) 
13.3 
EQ-5D-Y Proxy Version 1 
13.3.1 EQ-5D-Y Proxy Version 1 Dimension 
For each of the 5 dimensions based on the descriptive system of the EQ-5D-Y, self-report 
version, the numbers and percentages of subjects for all categories (the three levels of reported 
problems and question not completed) at baseline and each of the post-HSCT assessments will 
be presented. For each subject at a specific post-HSCT assessment, change between baseline and 
that assessment in each dimension will be categorized similarly to the change in each of the 5 
dimensions in EQ-5D-5L (Section 13.1.1). The numbers and percentages of subjects for all 
categories in change between baseline and each of the post-HSCT assessments will be presented 
for each dimension.  
 
The following summaries will be provided: 
• Summary of EQ-5D-Y dimensions for pediatric subjects (age ≥4 and ≤7 years) by 
assessment 
• Summary of change in EQ-5D-Y dimensions from baseline for pediatric subjects (age ≥4 
and ≤7 years) by assessment 
 
The following listing will be provided and will include results for each of the 5 dimensions and 
the VAS score: 
• Listing of EQ-5D-Y Proxy Version 1 
 
13.3.2 EQ VAS Score 
The EQ VAS score at baseline and each of the post-HSCT assessments will be summarized and 
presented using descriptive statistics. For each of the post-HSCT assessments, change between 
baseline and that assessment in the EQ VAS score will be calculated as mentioned in Section 
13.1.2 for a specified subject, and will be summarized and presented using descriptive statistics.  
 
The following summary will be provided: 
• Summary of EQ VAS score for pediatric subjects (age ≥4 and ≤7 years)  
 
14 BIOMARKERS 
Biomarker analysis is not within the scope of this SAP and a separate report will be provided for 
the analysis of biomarkers. 
 
15 IMMUNOGENICITY 
Immunogenicity analysis is not within the scope of this SAP and a separate report will be 
provided for the analysis. 
 


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16 PHARMACOKINETIC ANALYSES 
16.1 
General Considerations 
Pharmacokinetic (PK) analysis for this study will be conducted in 2 separate efforts. For those 
subjects with intensive PK sampling scheme and those who developed VOD and received 
defibrotide rescue treatment, a noncompartmental analysis will be conducted and reported in this 
CSR. The PK sample collection schedule in subjects who developed VOD and received 
defibrotide rescue treatment underwent several changes across protocol amendments. The results 
of this analysis will be produced and summarized by day and time points as covered by the 
protocol version which was current at the time of PK sample collection, and as outlined in 
Sections 16.2 and 16.3. For those subjects with sparse PK sampling scheme, a population-based 
PK analysis will be conducted together with PK data from other studies. The population PK will 
be reported separately from the CSR. 
Quantitative variables will be summarized using descriptive statistics (sample size, arithmetic 
mean, SD, coefficient of variation, median, min, and max). Geometric statistics (mean and SD) 
will be included for PK concentrations and parameters, where applicable.  
All defibrotide concentration data will be reported and analyzed with the same precision as the 
source data provided by the bioanalytical laboratory regardless of how many significant figures 
or decimals the data carry. Derived PK parameters will be rounded for reporting purposes in 
listings. The rounded derived PK parameters will be considered the source data for the 
calculation of descriptive statistics and other statistical analysis. For most derived PK 
parameters, 3 significant digits will be used as the standard rounding procedure, with the 
following exceptions: 
o Parameters directly derived from source data (eg, maximum defibrotide concentration 
[Cmax]) will be reported and analyzed with the same precision as the source data. 
o Parameters derived from actual elapsed sample collection times (eg, time to maximum 
activity [Tmax]) will be reported with the same precision as the actual elapsed sampling 
time value of the source data. 
For the reporting of descriptive statistics, the arithmetic and geometric means and SDs will be 
presented with precision of 1 digit more than the source data. The minimum, median, and 
maximum will be presented with the same precision as the source data. Coefficients of variation 
will always be reported with 1 decimal place. 
16.2 
Defibrotide Plasma Concentrations 
The defibrotide plasma concentrations will be summarized by nominal time point using 
descriptive statistics as described in Section 16.1. Concentrations that are below the limit of 
quantitation (BLQ) will be treated as a numeric value of 0, and the associated geometric statistics 
will be designated and reported as not done. 
The following summaries will be provided: 
• Summary of defibrotide plasma concentrations in subjects consented for intensive PK 
collection  


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o On Day +1 and Day +7 post-HSCT: prior to defibrotide infusion, and 2, 2.25, 2.5, 
2.75, 3, 3.5, 4 and 5 hours after start of defibrotide infusion;  
o On Day +15 and Day +30 post-HSCT: 2 hours post start of defibrotide infusion;  
• Summary of defibrotide plasma concentrations in subjects with sparse PK sampling 
o On Day +7 post-HSCT: 2 hours post start of defibrotide infusion, 2 to 4 hours 
after the end of defibrotide infusion; 
o On Day +15 and Day +30 post-HSCT: 2 hours post start of defibrotide infusion; 
• Summary of defibrotide plasma concentrations in subjects who developed VOD and 
received defibrotide rescue treatment by treatment arm (BSC or DP) 
o On Day 1 after the start of rescue treatment: prior to defibrotide infusion, and 2, 3, 
4 and 5 hours after start of defibrotide infusion (Protocol Amendment 3); 
o On Day 7 after the start of rescue treatment: 2 hours post start of defibrotide 
infusion (Protocol Amendment 3); 
o On Day 14 after the start of rescue treatment: prior to defibrotide infusion, at 2 
hours post start of defibrotide infusion, and at 1, 2 and 3 hours after end of 
defibrotide infusion (Original Protocol), or prior to defibrotide infusion, and 2, 3, 
4 and 5 hours after start of defibrotide infusion (Protocol Amendments 1&2) 
o On Day 30 after the start of rescue treatment: 2 hours post start of defibrotide 
infusion (Original Protocol, and Protocol Amendments 1&2); 
Figures of individual and arithmetic mean defibrotide concentration-time profiles (± SD, as 
appropriate) using nominal time points in patients consented to intensive PK collection on Day 
+1 and Day +7 post-HSCT and in patients receiving defibrotide rescue treatment on Day 1 and 
Day 14 after the start of recue treatment, will be presented on linear and semi-logarithmic scales. 
For graphing purposes, the BLQ values will be considered as missing and, if applicable, 2 
neighboring values will be connected.  
The following figures will be provided: 
• Mean Defibrotide Plasma Concentration-time Profile on Linear and Semi-logarithmic 
Scales following Defibrotide Infusion at 6.25 mg/kg on Day +1 post-HSCT 
• Mean Defibrotide Plasma Concentration-time Profile on Linear and Semi-logarithmic 
Scales following Defibrotide Infusion at 6.25 mg/kg on Day +7 post-HSCT 
• Mean Defibrotide Plasma Concentration-time Profile on Linear and Semi-logarithmic 
Scales following Defibrotide Infusion at 6.25 mg/kg after the start of rescue treatment in 
Patients from DP Arm by Visit  
• Mean Defibrotide Plasma Concentration-time Profile on Linear and Semi-logarithmic 
Scales following Defibrotide Infusion at 6.25 mg/kg after the start of rescue treatment in 
Patients from BSC Arm by Visit  
A listing of all defibrotide plasma concentrations by subject, with visit (day), study arm, PK 
blood sample collection date/time, calculated actual collection times relative to the previous 
dose, and derived sampling time deviations will be provided: 


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• Listing of defibrotide plasma concentrations 
 
16.3 
Defibrotide Pharmacokinetic Parameters 
Subjects with partial defibrotide concentrations data, protocol violations or events with the 
potential to affect PK will be evaluated on a case-by-case basis to determine if sufficient data are 
available for reliable estimation of PK parameters. 
  
PK parameters will be calculated for he patients consented for intensive PK collection on Day +1 
and Day +7 post-HSCT; and for patients who developed VOD and received defibrotide for 
rescue treatment on Day 1 (Protocol Amendment 3) and on Day 14 (Original Protocol, and 
Protocol Amendments 1&2) after the start of rescue treatment, as data permit. 
 
The defibrotide plasma PK parameters will be calculated using the standard noncompartmental 
analysis methods according to current working practices and Phoenix WinNonlin (Certara USA, 
Inc., v6.3 or higher).  
 
All calculations of noncompartmental parameters will be based on actual sampling times for the 
analysis, but all predose times will be assigned a numerical value of 0 to prevent overestimation 
of the AUC. 
 
Defibrotide plasma concentrations that are BLQ or missing will be handled the following way: 
o Predose samples concentrations that are BLQ or missing will be assigned a numerical 
value of 0. 
o Any other BLQ value will be assigned a value of 0 if they precede quantifiable 
samples in the initial portion of the profile.  
o A BLQ value that occurs between quantifiable data points, especially prior to Cmax, 
will be evaluated to determine if an assigned value of 0 makes sense, or if exclusion 
of the data (flagged in the data and identified to be treated as missing) is warranted.  
o Following Cmax, the BLQ values embedded between 2 quantifiable data points will be 
treated as missing when calculating PK parameters. 
o If a BLQ value occurs at the end of the collection interval (after the last quantifiable 
activity), it will be set to 0.  
o If consecutive BLQ values are followed by quantifiable values in the terminal portion 
of the concentration curve, these quantifiable values will be excluded from the PK 
analysis by setting them to missing, unless otherwise warranted by the 
concentration-time profile.  
 
Where possible the following PK parameters listed in Table 6 will be determined from 
defibrotide plasma concentrations. 
 
Table 6. PK Parameters to be Summarized  


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Cmax 
Maximum defibrotide plasma concentration, obtained directly from the observed 
data 
Tmax 
Time of maximum defibrotide concentration (in hours), obtained directly from the 
observed data 
Clast 
The last quantifiable defibrotide concentration, obtained directly from observed 
data 
Tlast 
Time of the last quantifiable defibrotide concentration (in hours), obtained directly 
from the observed data 
AUC0-t  
Area under the defibrotide concentration-time curve in the sampled matrix from 0 
(predose) to time of last quantifiable defibrotide concentration at time “t” 
AUCtau 
Area under the defibrotide plasma concentration-time curve from 0 (predose) to the 
end of the dosing period  (Day +7 post-HSCT and Days 1 and 14 after the start of 
rescue treatment in patients from DP arm ) 
AUC0-inf 
Area under the defibrotide plasma concentration-time curve from 0 (predose), 
extrapolated to infinity by addition of the last quantifiable concentration divided by 
the elimination rate constant to AUC0-t:  AUC0-t + Clast / λz (Day +1 post-HSCT and 
Day 1 after the start of recue treatment in patients from BSC arm ) 
 λz (kel) 
Apparent terminal elimination rate constant (in 1/hour), determined by linear 
regression of the terminal points of the log-linear defibrotide concentration-time 
curve  
Visual assessment will be used to identify the terminal linear phase of the 
defibrotide concentration-time profile. A minimum of 3 data points will be used for 
the determination. 
t1/2 
Terminal elimination half-life (in hours): ln(2) / λz 
CL 
Systemic clearance after intravenous dosing, calculated as  
• Dose/AUC0-inf (Day +1 post-HSCT and Day 1 after the start of rescue 
treatment in patients from BSC arm) 
• Dose/AUCtau (Day +7 post-HSCT and Days 1 and 14 after the start of 
rescue treatment in patients from DP arm) 
Vss 
Estimate of the volume of distribution at steady state following intravenous dosing: 
MRT0-inf × CL, where MRT0-inf is mean residence time extrapolated to infinity 
 
All AUC parameters will be calculated using Linear trapezoidal / Linear Interpolation 
trapezoidal summation. The minimum requirement for the calculation of AUC will be the 


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inclusion of at least 3 consecutive plasma concentrations above the lower limit of quantification, 
with at least 1 of these concentrations following Cmax. 
 
The PK parameters listed in Table 7 will be calculated for diagnostic or parameter derivation 
purposes and listed, but will not be summarized. 
 
Table 7. PK Parameters for Diagnostic or Parameter Derivation Purposes 
Span  
The time spanned by λz (upper λz – lower λz) divided by the estimated t1/2.  
The t1/2 will be estimated over a time period of at least 2 half-lives, where possible. 
Where a t1/2 is estimated over a time period of less than 2 half-lives, it may be 
flagged in the data listings at the discretion of the Pharmacokineticist, and the 
robustness of the value will be discussed in the CSR. 
t1/2, N 
Number of data points included in the log-linear regression analysis to determine 
λz 
A minimum of 3 data points will be used for determination. 
Rsq, 
adjusted 
Goodness of fit statistic for calculation of λz  
A value of ≥ 0.8 for the adjusted R-squared value will be used as the criterion for 
the reliable estimation of λz and reporting of the t1/2. If the adjusted R-squared 
value does not meet this criterion for a given subject the t1/2, AUC0-inf, CL, and Vss 
will be listed but not included in the descriptive statistics. 
%AUCextr Percentage of AUC0-inf obtained by extrapolation: [(Clast / λz) / AUC0-inf × 100]  
If %AUCextr is greater than 20% of AUC0-inf, then AUC0-inf, CL, and Vss will be 
listed but not included in summary statistics. 
AUMClast Area under the first moment curve (AUMC) from 0 (pre-dose) to time of last 
quantifiable defibrotide concentration at time “t” 
AUMC0-
inf 
Area under the first moment curve (AUMC) extrapolated to infinity, based on the 
last observed concentration, calculated as AUMClast + (Tlast × Clast) / λz + Clast / λz 
MRT0-inf 
Mean residence time extrapolated to infinity, calculated for infusion models as 
(AUMC0-inf/ AUC0-inf – TI / 2, where TI is infusion time 
 
All PK parameters will be summarized by visit and study arm using descriptive statistics as 
described in Section 16.1. Geometric mean will not be calculated for Tmax and Tlast.  
 
The following summaries will be provided: 
• Defibrotide plasma pharmacokinetic parameters following defibrotide infusion at 
6.25 mg/kg on Day +1 post-HSCT 


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• Defibrotide plasma pharmacokinetic parameters following defibrotide infusion at 
6.25 mg/kg on Day +7 post-HSCT 
• Defibrotide plasma pharmacokinetic parameters following defibrotide infusion at 
6.25 mg/kg after the start of rescue treatment by Visit.  
 
The following listing will be provided and will include all generated individual PK parameters 
by subject, visit (day), and treatment arm: 
• Listing of PK parameters 
 
 
17 PHARMACODYNAMIC ANALYSES 
Not applicable. 
 
18 COVID-19 
Comments identifying missed visits, missed assessments, study drug discontinuation, and/or 
study participation termination due to COVID-19 will be captured in EDC. Additionally, 
comments will be captured in EDC if a visit is performed as a remote voice or video visit. 
Comments will specify if the study disruption was due to acquiring COVID-19 or due to other 
COVID-19 restrictions.  
 
The following listing will be provided and will include all subjects affected by the COVID-19 
related study disruption by unique subject number identifier and by investigational site, and a 
description of how the individual’s participation was altered: 
• Listing of subjects impacted by the COVID-19 pandemic 
 


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19 REFERENCES 
1. Collett, D. (2003) Modelling Survival Data in Medical Research (Second ed.). Chapman 
and Hall/CRC. 
2. Corbacioglu, S., Cesaro, S., Faraci, M., et al. (2012) Defibrotide for prophylaxis of 
hepaticvenoocclusive disease in pediatric haematopoietic stem-cell transplantation: an 
open-label, phase 3, randomised controlled trial. Lancet, 379(9823), 1301-9. 
3. Cui, L., Hung, H.M., Wang, S.J. (1999) Modification of sample size in group sequential 
clinical trials. Biometrics, 55(3), 853-857. 
4. Gray, R.J. (1988) A Class of K-sample tests for comparing the cumulative incidence of a 
competing risk. Annals Stat., 16(3), 1141-1154. 
5. Jacobsohn, D.A., Vogelsang, G.B. (2007). Acute graft versus host disease. Orphanet J 
Rare Dis, 2:35. 
6. Marubini, E., Valsecchi, M.G. (1995) Analysing Survival Data from Clinical Trials and 
Observational Studies, Statistics in Practice, ed. Vic Barnett. Chichester: John Wiley & 
Sons, Available upon request. 
 
 
 
 
 
 
 
 
 
 
 


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20 APPENDIX I: PREFFERRED TERMS FOR ADVERSE EVENTS OF 
SPECIAL INTEREST  
20.1 
PTs for Pulmonary Hemorrhage  
Bronchial haemorrhage 
Bronchial varices haemorrhage 
Epistaxis 
Haemoptysis 
Pulmonary alveolar haemorrhage  
Pulmonary haemorrhage 
Pulmonary haematoma 
Respiratory tract haemorrhage 
Respiratory tract haemorrhage neonatal 
Tracheal haemorrhage 
 
20.2 
PTs for Gastrointestinal Bleeding 
Chronic gastrointestinal bleeding 
Colonic haematoma 
Diarrhoea haemorrhagic 
Duodenal ulcer haemorrhage 
Duodenitis haemorrhagic 
Enterocolitis haemorrhagic 
Gastric haemorrhage 
Gastric occult blood positive 
Gastric ulcer haemorrhage 
Gastric ulcer haemorrhage, obstructive 
Gastritis haemorrhagic 
Gastroduodenal haemorrhage 
Gastroduodenitis haemorrhagic 
Gastrointestinal haemorrhage 
Haematemesis 
Haematochezia 
Haemorrhagic erosive gastritis 
Intestinal hematomashaematoma 
Intestinal haemorrhage 
Intestinal varices haemorrhage 
Intra-abdominal haematoma 
Large intestinal haemorrhage 
Large intestinal ulcer haemorrhage 
Lower gastrointestinal haemorrhage 
Melaena 


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Mesenteric haemorrhage 
Occult blood positive 
Oesophageal haemorrhage 
Oesophageal intramural haematoma 
Oesophageal ulcer haemorrhage 
Oesophagitis haemorrhagic 
Peptic ulcer haemorrhage 
Proctitis haemorrhagic 
Rectal haemorrhage 
Rectal ulcer haemorrhage 
Small intestinal haemorrhage 
Small intestinal ulcer haemorrhage 
Ulcer haemorrhage 
Upper gastrointestinal haemorrhage 
 
20.3 
PTs for Gastrointestinal Bleeding likely pre-existing neurological or neonatal 
conditions 
Anal haemorrhage 
Anal ulcer haemorrhage 
Anastomotic haemorrhage 
Anastomotic ulcer haemorrhage 
Anorectal varices haemorrhage 
Diverticulitis intestinal haemorrhagic 
Diverticulum intestinal haemorrhagic 
Duodenal operation 
Duodenal vascular ectasia 
Gastric antral vascular ectasia 
Gastric haemangioma 
Gastric varices haemorrhage 
Gastritis alcoholic haemorrhagic 
Gastrointestinal anastomotic leak 
Gastrointestinal angiectasia 
Gastrointestinal angiodysplasia haemorrhagic 
Gastrointestinal polyp haemorrhage 
Haemorrhoidal haemorrhage 
Mallory-Weiss syndrome 
Melaena neonatal 
Neonatal gastrointestinal haemorrhage 
Oesophageal varices haemorrhage 
White nipple sign 
 


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20.4 
PTs for Hypersensitivity Reactions 
Acute generalised exanthematous pustulosis 
Administration site dermatitis 
Administration site eczema 
Administration site hypersensitivity 
Administration site rash 
Administration site recall reaction 
Administration site urticaria 
Administration site vasculitis 
Allergic bronchitis 
Allergic colitis 
Allergic cough 
Allergic cystitis 
Allergic eosinophilia 
Allergic gastroenteritis 
Allergic hepatitis 
Allergic keratitis 
Allergic myocarditis 
Allergic oedema 
Allergic otitis externa 
Allergic otitis media 
Allergic pharyngitis 
Allergic respiratory disease 
Allergic respiratory symptom 
Allergic sinusitis 
Allergic transfusion reaction 
Allergy alert test positive 
Allergy test positive 
Allergy to immunoglobulin therapy 
Allergy to surgical sutures 
Allergy to vaccine 
Alveolitis allergic 
Anaphylactic reaction 
Anaphylactic shock 
Anaphylactic transfusion reaction 
Anaphylactoid reaction 
Anaphylactoid shock 
Anaphylaxis treatment 
Angioedema 
Anti-neutrophil cytoplasmic antibody positive vasculitis 
Antiallergic therapy 
Antiendomysial antibody positive 


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Application site dermatitis 
Application site eczema 
Application site hypersensitivity 
Application site rash 
Application site recall reaction 
Application site urticaria 
Application site vasculitis 
Arthritis allergic 
Aspirin-exacerbated respiratory disease 
Atopy 
Blepharitis allergic 
Blood immunoglobulin E abnormal 
Blood immunoglobulin E increased 
Bromoderma 
Bronchospasm 
Catheter site dermatitis 
Catheter site eczema 
Catheter site hypersensitivity 
Catheter site rash 
Catheter site urticaria 
Catheter site vasculitis 
Chronic eosinophilic rhinosinusitis 
Chronic hyperplastic eosinophilic sinusitis 
Circulatory collapse 
Circumoral oedema 
Conjunctival oedema 
Conjunctivitis allergic 
Contact stomatitis 
Contrast media allergy 
Contrast media reaction 
Corneal oedema 
Cutaneous vasculitis 
Dennie-Morgan fold 
Dermatitis 
Dermatitis acneiform 
Dermatitis allergic 
Dermatitis atopic 
Dermatitis bullous 
Dermatitis contact 
Dermatitis exfoliative 
Dermatitis exfoliative generalised 
Dermatitis herpetiformis 
Dermatitis infected 


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Dermatitis psoriasiform 
Device allergy 
Dialysis membrane reaction 
Distributive shock 
Documented hypersensitivity to administered product 
Drug cross-reactivity 
Drug eruption 
Drug hypersensitivity 
Drug provocation test 
Drug reaction with eosinophilia and systemic symptoms 
Eczema 
Eczema infantile 
Eczema nummular 
Eczema vaccinatum 
Eczema vesicular 
Eczema weeping 
Encephalitis allergic 
Encephalopathy allergic 
Eosinophilic granulomatosis with polyangiitis 
Epidermal necrosis 
Epidermolysis 
Epidermolysis bullosa 
Epiglottic oedema 
Erythema multiforme 
Erythema nodosum 
Exfoliative rash 
Eye allergy 
Eye oedema 
Eye swelling 
Eyelid oedema 
Face oedema 
Fixed drug eruption 
Giant papillary conjunctivitis 
Gingival oedema 
Gingival swelling 
Gleich's syndrome 
Haemorrhagic urticaria 
Hand dermatitis 
Henoch-Schonlein purpura 
Henoch-Schonlein purpura nephritis 
Heparin-induced thrombocytopenia 
Hereditary angioedema 
Hypersensitivity 


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Hypersensitivity vasculitis 
Idiopathic urticaria 
Immediate post-injection reaction 
Immune thrombocytopenic purpura 
Immune tolerance induction 
Immune-mediated adverse reaction 
Implant site dermatitis 
Implant site hypersensitivity 
Implant site rash 
Implant site urticaria 
Incision site dermatitis 
Incision site rash 
Infusion site dermatitis 
Infusion site eczema 
Infusion site hypersensitivity 
Infusion site rash 
Infusion site recall reaction 
Infusion site urticaria 
Infusion site vasculitis 
Injection site dermatitis 
Injection site eczema 
Injection site hypersensitivity 
Injection site rash 
Injection site recall reaction 
Injection site urticaria 
Injection site vasculitis 
Instillation site hypersensitivity 
Instillation site rash 
Instillation site urticaria 
Interstitial granulomatous dermatitis 
Intestinal angioedema 
Iodine allergy 
Kaposi's varicelliform eruption 
Kounis syndrome 
Laryngeal oedema 
Laryngitis allergic 
Laryngospasm 
Laryngotracheal oedema 
Limbal swelling 
Lip oedema 
Lip swelling 
Mast cell degranulation present 
Medical device site dermatitis 


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Medical device site eczema 
Medical device site hypersensitivity 
Medical device site rash 
Medical device site recall reaction 
Medical device site urticaria 
Mouth swelling 
Mucocutaneous rash 
Multiple allergies 
Nephritis allergic 
Nikolsky's sign 
Nodular rash 
Oculomucocutaneous syndrome 
Oculorespiratory syndrome 
Oedema mouth 
Oral allergy syndrome 
Oropharyngeal blistering 
Oropharyngeal spasm 
Oropharyngeal swelling 
Palatal oedema 
Palatal swelling 
Palisaded neutrophilic granulomatous dermatitis 
Palpable purpura 
Pathergy reaction 
Periorbital oedema 
Pharyngeal oedema 
Pruritus allergic 
Radioallergosorbent test positive 
Rash 
Rash erythematous 
Rash follicular 
Rash generalised 
Rash macular 
Rash maculo-papular 
Rash maculovesicular 
Rash morbilliform 
Rash neonatal 
Rash papulosquamous 
Rash pruritic 
Rash pustular 
Rash rubelliform 
Rash scarlatiniform 
Rash vesicular 
Reaction to azo-dyes 


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Reaction to colouring 
Reaction to drug excipients 
Reaction to preservatives 
Red man syndrome 
Rhinitis allergic 
Scleral oedema 
Scleritis allergic 
Scrotal oedema 
Serum sickness 
Serum sickness-like reaction 
Shock 
Shock symptom 
Skin necrosis 
Skin reaction 
Skin test positive 
Solar urticaria 
Solvent sensitivity 
Stevens-Johnson syndrome 
Stoma site hypersensitivity 
Stoma site rash 
Swelling face 
Swollen tongue 
Symmetrical drug-related intertriginous and flexural 
exanthema 
Tongue oedema 
Toxic epidermal necrolysis 
Toxic skin eruption 
Tracheal oedema 
Type I hypersensitivity 
Type II hypersensitivity 
Type III immune complex mediated reaction 
Type IV hypersensitivity reaction 
Urticaria 
Urticaria cholinergic 
Urticaria chronic 
Urticaria contact 
Urticaria papular 
Urticaria physical 
Urticaria pigmentosa 
Urticaria vesiculosa 
Urticarial vasculitis 
Vaccination site dermatitis 
Vaccination site eczema 


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Vaccination site exfoliation 
Vaccination site hypersensitivity 
Vaccination site rash 
Vaccination site recall reaction 
Vaccination site urticaria 
Vaccination site vasculitis 
Vaccination site vesicles 
Vaginal exfoliation 
Vaginal ulceration 
Vasculitic rash 
Vessel puncture site rash 
Vessel puncture site vesicles 
Vulval ulceration 
Vulvovaginal rash 
Vulvovaginal ulceration