Vedolizumab in the Prophylaxis of Intestinal Acute Graft... | NCT03657160

NCT03657160

ID	Type	Description
2018-002141-11	EudraCT Number
JapicCTI-184221	Registry Identifier	JapicCTI
U1111-1216-2319	Registry Identifier	WHO

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).	Drug: Vedolizumab Placebo
Vedolizumab 300 mg	Experimental	Vedolizumab 300 mg, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).	Drug: Vedolizumab

Name	Type	Description	Arm Group Labels	Other Names
Vedolizumab Placebo	Drug	Vedolizumab placebo-matching IV infusion.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days	Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.	From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days

Secondary Outcomes

Measure	Description	Time Frame
Intestinal aGvHD-Free and Relapse-Free Survival	Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.

Eligibility Module

Name	Affiliation	Role
Medical Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham Comprehensive Cancer Center		Birmingham	Alabama	35294	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38844797	Derived	Chen YB, Mohty M, Zeiser R, Teshima T, Jamy O, Maertens J, Purtill D, Chen J, Cao H, Rossiter G, Jansson J, Floisand Y. Vedolizumab for the prevention of intestinal acute GVHD after allogeneic hematopoietic stem cell transplantation: a randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2277-2287. doi: 10.1038/s41591-024-03016-4. Epub 2024 Jun 6.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 18, 2019	Dec 8, 2022

Arm/Group Information

ID	Title	Description
BG000	Placebo	Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
BG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00051.9± 14.49 BG00150.8± 14.41 BG00251.4± 14.44

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000106 BG001103 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG00116 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days

Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.

FAS included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo HSCT. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.

Posted

Median

Full Range

days

From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days

ID	Title	Description
OG000	Placebo	Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
OG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).

Units	Counts
Participants	OG000165 OG001168

Title

Denominators

Categories

Title	Measurements
	OG000NA(14 to 182)The median was not estimable due to censoring of participants. OG001NA(2 to 182)The median was not estimable due to censoring of participants.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.001		Hazard Ratio (HR)	0.45			2-Sided	95	0.27	0.73					Superiority

Secondary

Intestinal aGvHD-Free and Relapse-Free Survival

Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.

Posted

Median

Full Range

days

From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180

ID	Title	Description
OG000	Placebo	Vedolizumab placebo-matching, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
OG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).

Secondary

Grade C-D aGvHD-Free Survival

Grade C-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death, where an event is defined as Grade C-D aGvHD any organ involvement per International Bone Marrow Transplant Registry Database (IBMTR) Severity Index for aGvHD or death. It will be censored for participants who have not had the event or have had the event after pre-specified timing, eg, last contact or Day +180 after allo-HSCT whichever occurs first.

Posted

Median

Full Range

days

From the date of first dose of study drug to first documented Grade C-D aGvHD or death, whichever occurs first up to Day +180

ID	Title	Description
OG000	Placebo	Vedolizumab placebo-matching, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
OG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).

Secondary

Nonrelapse Mortality (NRM)

Non-relapse mortality is the time from the date of first study drug administration (Day-1) to death without occurrence of a relapse. Data was censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.

Posted

Median

Full Range

days

From the date of first dose of study drug to first documented death without relapse, up to Day +180

ID	Title	Description
OG000	Placebo	Vedolizumab placebo-matching, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
OG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).

Secondary

Overall Survival (OS)

Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.

Posted

Median

Full Range

days

From the date of first dose of study drug to first documented death up to Day +180

ID	Title	Description
OG000	Placebo	Vedolizumab placebo-matching, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
OG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).

Units	Counts
Participants

Secondary

Grade B-D aGvHD-Free Survival

Grade B-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to aGvHD event or death, where an event is defined as death or grade B-D any organ involvement per IBMTR Severity Index for aGvHD.

Posted

Median

Full Range

days

From the date of first dose of study drug to first documented grade B-D aGvHD or death, whichever occurs first up to Day +180

ID	Title	Description
OG000	Placebo	Vedolizumab placebo-matching, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
OG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).	34	169	114	165	164	165
EG001	Vedolizumab 300 mg	Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).	26	174	120	169	169	169

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG0003 affected165 at risk EG0011 affected169 at risk
Leukopenias	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0015 affected169 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG0008 affected165 at risk EG0017 affected169 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Cardiac failures	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected169 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Myocardial infarction	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Myocarditis	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Pericardial effusion	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Tachycardia	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Atrial flutter	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Cardiac arrest	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0016 affected169 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0012 affected169 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Vomiting	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0014 affected169 at risk
Nausea	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected169 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Stomatitis	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0015 affected169 at risk
Asthenia	General disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Fatigue	General disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Malaise	General disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Hyperthermia	General disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Pyrexia	General disorders	MedDRA24.0	Systematic Assessment	EG00013 affected165 at risk EG00113 affected169 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA24.0	Systematic Assessment	EG0003 affected165 at risk EG0015 affected169 at risk
Disease progression	General disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Influenza like illness	General disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Polyserositis	General disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Chest discomfort	General disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Chest pain	General disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Perforated ulcer	General disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Choleostasis	Hepatobiliary disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Liver disorder	Hepatobiliary disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0012 affected169 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA24.0	Systematic Assessment	EG00016 affected165 at risk EG0016 affected169 at risk
Acute graft versus host disease	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0005 affected165 at risk EG0012 affected169 at risk
Acute graft versus host disease in liver	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0015 affected169 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0013 affected169 at risk
Chronic graft versus host disease	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected169 at risk
Engraftment syndrome	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected169 at risk
Chronic graft versus host disease in liver	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected169 at risk
Graft versus host disease in eye	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Acute graft versus host disease oral	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Chronic graft versus host disease in lung	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Chronic graft versus host disease in skin	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Chronic graft versus host disease oral	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Graft versus host disease in lung	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Enterocolitis infectious	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Diverticulitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Gastroenteritis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Acinetobacter infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Anorectal cellulitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Bacterial infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Systemic candida	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Encephalitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Extradural abscess	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Clostridium difficile infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
COVID-19	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0016 affected169 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Epstein-Barr virus infection reactivation	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected169 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Escherichia infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Escherichia sepsis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Fungal infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Sinusitis fungal	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Herpes zoster	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected169 at risk
Human herpesvirus 6 encephalitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected169 at risk
Respiratory tract infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Wound infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Klebsiella bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Klebsiella sepsis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Pneumonia	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0008 affected165 at risk EG0015 affected169 at risk
Tracheobronchitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Atypical pneumonia	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Bronchitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Lung abscess	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Epididymitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
BK virus infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Human polyomavirus infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Rhinovirus infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Sepsis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0009 affected165 at risk EG0014 affected169 at risk
Septic shock	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0014 affected169 at risk
Bacteraemia	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0005 affected165 at risk EG0010 affected169 at risk
Device related sepsis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Neutropenic sepsis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Septic embolus	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Septic encephalopathy	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Skin infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Cerebral toxoplasmosis	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Urinary tract infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Vascular device infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Meningitis viral	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Viral infection	Infections and infestations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Fall	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Prescribed overdose	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Engraft failure	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0014 affected169 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0013 affected169 at risk
Delayed engraftment	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Pseudomonas test positive	Investigations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Blast cell count increased	Investigations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Alanine aminotransferase increased	Investigations	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0019 affected169 at risk
Aspartate aminotransferase increased	Investigations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected169 at risk
Blood bilirubin increased	Investigations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Liver function test abnormal	Investigations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Neutrophil count decreased	Investigations	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected169 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected169 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
T-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected169 at risk
Diffuse large B-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Minimal residual disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Central nervous system leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Acute lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0013 affected169 at risk
Philadelphia positive acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0009 affected165 at risk EG0019 affected169 at risk
Chronic myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0013 affected169 at risk
Chloroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected169 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0003 affected165 at risk EG0015 affected169 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Peripheral T-cell lymphoma unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Hemorrhage intracranial	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Ischaemic stroke	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Ataxia	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected169 at risk
Syncope	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Altered state of consciousness	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Encephalopathy	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected169 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Facial paralysis	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Presyncope	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Seizure	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Epilepsy	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Partial seizures	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Neuralgia	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Confusional state	Psychiatric disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Delirium	Psychiatric disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0013 affected169 at risk
Mental status changes	Psychiatric disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Micturition urgency	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0014 affected169 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0008 affected165 at risk EG0013 affected169 at risk
Renal failure	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected169 at risk
Prerenal failure	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Renal impairment	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Haematuria	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected169 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Bronchiolitis obliterans syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Epiglottic oedema	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0003 affected165 at risk EG0012 affected169 at risk
Idiopathic pneumonia syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected169 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected169 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0003 affected165 at risk EG0015 affected169 at risk
Acute Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Shock haemorrhagic	Vascular disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Venoocclusive disease	Vascular disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected169 at risk
Hypertension	Vascular disorders	MedDRA24.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected169 at risk
Hypotension	Vascular disorders	MedDRA24.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected169 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG000102 affected165 at risk EG00195 affected169 at risk
Stomatitis	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00090 affected165 at risk EG00190 affected169 at risk
Nausea	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00083 affected165 at risk EG00185 affected169 at risk
Pyrexia	General disorders	MedDRA24.0	Systematic Assessment	EG00062 affected165 at risk EG00180 affected169 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG00072 affected165 at risk EG00168 affected169 at risk
Acute Graft Versus Host Disease in Skin	Immune system disorders	MedDRA24.0	Systematic Assessment	EG00065 affected165 at risk EG00167 affected169 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG00054 affected165 at risk EG00167 affected169 at risk
Headache	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG00058 affected165 at risk EG00158 affected169 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00052 affected165 at risk EG00160 affected169 at risk
Hypertension	Vascular disorders	MedDRA24.0	Systematic Assessment	EG00054 affected165 at risk EG00154 affected169 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00054 affected165 at risk EG00147 affected169 at risk
Vomiting	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00055 affected165 at risk EG00141 affected169 at risk
Constipation	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00047 affected165 at risk EG00143 affected169 at risk
Fatigue	General disorders	MedDRA24.0	Systematic Assessment	EG00050 affected165 at risk EG00138 affected169 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00040 affected165 at risk EG00145 affected169 at risk
Platelet Count Decreased	Investigations	MedDRA24.0	Systematic Assessment	EG00047 affected165 at risk EG00138 affected169 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG00036 affected165 at risk EG00143 affected169 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG00031 affected165 at risk EG00143 affected169 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA24.0	Systematic Assessment	EG00032 affected165 at risk EG00140 affected169 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00035 affected165 at risk EG00134 affected169 at risk
Insomnia	Psychiatric disorders	MedDRA24.0	Systematic Assessment	EG00032 affected165 at risk EG00135 affected169 at risk
Cytomegalovirus Infection Reactivation	Infections and infestations	MedDRA24.0	Systematic Assessment	EG00028 affected165 at risk EG00137 affected169 at risk
Oedema Peripheral	General disorders	MedDRA24.0	Systematic Assessment	EG00035 affected165 at risk EG00129 affected169 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA24.0	Systematic Assessment	EG00026 affected165 at risk EG00136 affected169 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG00033 affected165 at risk EG00128 affected169 at risk
Blood Creatinine Increased	Investigations	MedDRA24.0	Systematic Assessment	EG00035 affected165 at risk EG00124 affected169 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG00020 affected165 at risk EG00136 affected169 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA24.0	Systematic Assessment	EG00025 affected165 at risk EG00130 affected169 at risk
Dry Eye	Eye disorders	MedDRA24.0	Systematic Assessment	EG00021 affected165 at risk EG00134 affected169 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00028 affected165 at risk EG00127 affected169 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG00025 affected165 at risk EG00126 affected169 at risk
Blood Bilirubin Increased	Investigations	MedDRA24.0	Systematic Assessment	EG00027 affected165 at risk EG00121 affected169 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG00022 affected165 at risk EG00123 affected169 at risk
Dizziness	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG00023 affected165 at risk EG00121 affected169 at risk
Dysgeusia	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG00021 affected165 at risk EG00123 affected169 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG00019 affected165 at risk EG00124 affected169 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG00020 affected165 at risk EG00121 affected169 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00022 affected165 at risk EG00119 affected169 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG00016 affected165 at risk EG00125 affected169 at risk
Tremor	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG00021 affected165 at risk EG00119 affected169 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG00022 affected165 at risk EG00116 affected169 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00017 events16 affected165 at risk EG00123 events22 affected169 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG00013 affected165 at risk EG00123 affected169 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG00017 affected165 at risk EG00118 affected169 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00017 affected165 at risk EG00117 affected169 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00020 affected165 at risk EG00113 affected169 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00018 affected165 at risk EG00115 affected169 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA24.0	Systematic Assessment	EG00016 affected165 at risk EG00117 affected169 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG00015 affected165 at risk EG00118 affected169 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00016 affected165 at risk EG00116 affected169 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00014 affected165 at risk EG00118 affected169 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA24.0	Systematic Assessment	EG00015 affected165 at risk EG00116 affected169 at risk
Hypotension	Vascular disorders	MedDRA24.0	Systematic Assessment	EG00012 affected165 at risk EG00119 affected169 at risk
Anxiety	Psychiatric disorders	MedDRA24.0	Systematic Assessment	EG00014 affected165 at risk EG00114 affected169 at risk
Neutrophil Count Decreased	Investigations	MedDRA24.0	Systematic Assessment	EG00015 affected165 at risk EG00113 affected169 at risk
White Blood Cell Count Decreased	Investigations	MedDRA24.0	Systematic Assessment	EG00018 affected165 at risk EG00110 affected169 at risk
Asthenia	General disorders	MedDRA24.0	Systematic Assessment	EG00012 affected165 at risk EG00114 affected169 at risk
Acute Graft Versus Host Disease In Intestine	Immune system disorders	MedDRA24.0	Systematic Assessment	EG00015 affected165 at risk EG00110 affected169 at risk
Dysuria	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG00012 affected165 at risk EG00113 affected169 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00011 affected165 at risk EG00113 affected169 at risk
Chronic Graft Versus Host Disease Oral	Immune system disorders	MedDRA24.0	Systematic Assessment	EG00010 affected165 at risk EG00114 affected169 at risk
Proctalgia	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00015 affected165 at risk EG0019 affected169 at risk
Chronic Graft Versus Host Disease In Skin	Immune system disorders	MedDRA24.0	Systematic Assessment	EG0007 affected165 at risk EG00116 affected169 at risk
Chronic Graft Versus Host Disease	Immune system disorders	MedDRA24.0	Systematic Assessment	EG00012 affected165 at risk EG00110 affected169 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG00015 affected165 at risk EG0017 affected169 at risk
Haematuria	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG00013 affected165 at risk EG0019 affected169 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0008 affected165 at risk EG00114 affected169 at risk
Chills	General disorders	MedDRA24.0	Systematic Assessment	EG00010 affected165 at risk EG00111 affected169 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00012 affected165 at risk EG0019 affected169 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0009 affected165 at risk EG00112 affected169 at risk
Vision Blurred	Eye disorders	MedDRA24.0	Systematic Assessment	EG00011 affected165 at risk EG00110 affected169 at risk
Oedema	General disorders	MedDRA24.0	Systematic Assessment	EG00013 affected165 at risk EG0017 affected169 at risk
Depression	Psychiatric disorders	MedDRA24.0	Systematic Assessment	EG0006 affected165 at risk EG00113 affected169 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0009 affected165 at risk EG00110 affected169 at risk
Oral Pain	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0007 affected165 at risk EG00112 affected169 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG0007 events6 affected165 at risk EG00112 events12 affected169 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG00013 events11 affected165 at risk EG0019 events7 affected169 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0009 events9 affected165 at risk EG0019 events9 affected169 at risk
Tachycardia	Cardiac disorders	MedDRA24.0	Systematic Assessment	EG0009 events6 affected165 at risk EG00113 events12 affected169 at risk
Fall	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG00011 events9 affected165 at risk EG0019 events8 affected169 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA24.0	Systematic Assessment	EG00011 events9 affected165 at risk EG0018 events7 affected169 at risk
Pollakiuria	Renal and urinary disorders	MedDRA24.0	Systematic Assessment	EG0008 events7 affected165 at risk EG0019 events9 affected169 at risk
Pain	General disorders	MedDRA24.0	Systematic Assessment	EG00011 affected165 at risk EG0014 affected169 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0009 affected165 at risk EG0016 affected169 at risk
Flatulence	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG00010 affected165 at risk EG0014 affected169 at risk
Confusional State	Psychiatric disorders	MedDRA24.0	Systematic Assessment	EG00010 affected165 at risk EG0013 affected169 at risk
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0019 affected169 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA24.0	Systematic Assessment	EG0004 affected165 at risk EG0019 affected169 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA24.0	Systematic Assessment	EG0003 affected165 at risk EG0019 affected169 at risk