A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cy... | NCT01877655

ID	Type	Description	Link
2013-000903-18	EudraCT Number

Label	Type	Description	Intervention Names
ASP0113	Experimental	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).	Biological: ASP0113
Placebo	Placebo Comparator	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ASP0113	Biological	Intramuscular injection	ASP0113
Placebo

Measure	Description	Time Frame
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant	This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.	From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

Measure	Description	Time Frame
Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant	Protocol-defined CMV viremia was defined as a CMV plasma viral load ≥1000 IU/mL as assessed by the central laboratory. Rate was based on cumulative incidence function estimated at 1 year. The central laboratory had the lower limit of quantification [LLOQ] for CMV viral load assessment, so when the viral load was below the LLOQ the actual viral load reading was not possible and was denoted as ≤LLOQ. If participant had any CMV viral load assessments greater than the LLOQ it was classified as viremic.

Name	Affiliation	Role
Medical Director	Astellas Pharma Global Development, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site US10028		Birmingham	Alabama	35294	United States
Site US10044

PubMed Identifier	Type	Citation	Retractions
33842870	Derived	Ljungman P, Bermudez A, Logan AC, Kharfan-Dabaja MA, Chevallier P, Martino R, Wulf G, Selleslag D, Kakihana K, Langston A, Lee DG, Solano C, Okamoto S, Smith LR, Boeckh M, Wingard JR, Cywin B, Fredericks C, Lademacher C, Wang X, Young J, Maertens J. A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients. EClinicalMedicine. 2021 Mar 19;33:100787. doi: 10.1016/j.eclinm.2021.100787. eCollection 2021 Mar.

Label	URL
Link to results and other applicable study documents on the Astellas Clinical Trials website	View source

ID	Title	Description
FG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
FG001	ASP0113 5mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 28, 2016	Sep 17, 2018

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The analysis population was the all randomized.

Mean

Standard Deviation

Year

Title

Denominators

Categories

Title	Measurements
	BG00052.0± 13.15 BG00151.8± 12.41 BG00251.9± 12.78

Sex: Female, Male

The analysis population was the all randomized.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000105 BG001110 BG002

Ethnicity (NIH/OMB)

The analysis population was the all randomized.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00011 BG00119 BG002

Race (NIH/OMB)

The analysis population was the all randomized.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Strata

The analysis population was the all randomized.

Count of Participants

Participants

Title

Denominators

Categories

Related Seropositive Donor

Title	Measurements
	BG00065 BG00173 BG002

Primary Diagnosis

The analysis population was the all randomized.

Count of Participants

Participants

Title

Denominators

Categories

Acute Myeloid Leukemia (AML)

Title	Measurements
	BG000126 BG00197 BG002

Conditioning Regimen

The analysis population was the all randomized.

Count of Participants

Participants

Title

Denominators

Categories

Myeloablative

Title	Measurements
	BG000122 BG001120 BG002

Antithymocyte Globulin (ATG) Use

The analysis population was the all randomized.

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00045 BG00143 BG002

Height

The analysis population was the all randomized.

Mean

Standard Deviation

Centimeteres

Title

Denominators

Categories

Title	Measurements
	BG000170.6± 9.91 BG001169.7± 9.88 BG002

Body Mass Index (BMI)

The analysis population was the all randomized.

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.0± 5.02 BG00126.0± 5.05 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

Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant

This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.

The analysis population was the full analysis set (FAS), which consisted of all randomized participants who received at least one dose of randomized study drug.

Posted

Number

Percentage of Participants

From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Units	Counts
Participants	OG000255 OG001246

Title

Denominators

Categories

Participants With Composite Endpoint

Title	Measurements
	OG00030.20 OG00135.37

All-Cause Mortality

Title	Measurements
	OG000

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	Analysis of all-cause mortality and adjudicated CMV EOD. Analysis was completed using the Cochran-Mantel-Haenszel (CMH) test at the 1-sided 5% level stratified by use of antithymocyte globulin (ATG) and by receipt of a kidney from a living or deceased donor.	Cochran-Mantel-Haenszel		0.205	P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.	Odds Ratio (OR)	1.27			2-Sided	95	0.87	1.85			Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness & donor CMV serostatus.

Secondary

Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant

Protocol-defined CMV viremia was defined as a CMV plasma viral load ≥1000 IU/mL as assessed by the central laboratory. Rate was based on cumulative incidence function estimated at 1 year. The central laboratory had the lower limit of quantification [LLOQ] for CMV viral load assessment, so when the viral load was below the LLOQ the actual viral load reading was not possible and was denoted as ≤LLOQ. If participant had any CMV viral load assessments greater than the LLOQ it was classified as viremic.

The analysis population was the FAS.

Posted

Number

95% Confidence Interval

Percentage of Participants

From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Secondary

Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant

The CMV-specific AVT use was adjudicated by the independent and blinded committee. When the CMV-specific AVT was initiated, a central CMV viral load was obtained weekly until it was discontinued. Participants without any CMV-specific AVT events were censored on the last study evaluation.

The analysis population was the FAS.

Posted

Number

95% Confidence Interval

Percentage of Participants

From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Units	Counts

Secondary

Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use

Protocol-defined CMV viremia was as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.

The analysis population was the FAS.

Posted

Number

Percentage of Participants

From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Units	Counts

Secondary

Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant

Rate was based on cumulative incidence function estimate at 1 year. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD were determined by the adjudication committee. This endpoint was a composite endpoint based on the independent adjudication committee assessments of CMV-specific AVT and CMV EOD.

The analysis population was the FAS.

Posted

Number

95% Confidence Interval

Percentage of Participants

From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Secondary

All-Cause Mortality at 1 Year Posttransplant

All-cause mortality through 1-year post-transplantation summary included all deaths and unknown survival status. For the known deaths, the adjudication committee assessed results and summarized them according to the following category: Mortality due to the participant's primary disease, and mortality due to causes unrelated to the participant's primary disease. Participants with unknown survival status at 1 year were considered dead for this analysis.

The analysis population was the FAS.

Posted

Number

Percentage of Participants

From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0004 events3 affected255 at risk EG0010 events0 affected246 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0014 events3 affected246 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0013 events3 affected246 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG00013 events11 affected255 at risk EG00114 events11 affected246 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected246 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0006 events5 affected255 at risk EG0016 events5 affected246 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected246 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Angina pectoris	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Arrhythmia	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0015 events4 affected246 at risk
Cardiac failure	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pericardial effusion	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Pericarditis	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Aural polyp	Ear and labyrinth disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Mydriasis	Eye disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0003 events2 affected255 at risk EG0012 events2 affected246 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Ascites	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Colitis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00011 events11 affected255 at risk EG00113 events10 affected246 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Enteritis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Gastritis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Gastrooesophagitis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Megacolon	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Nausea	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0008 events8 affected255 at risk EG00110 events10 affected246 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Oral pain	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG0007 events7 affected255 at risk EG00112 events11 affected246 at risk
Asthenia	General disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0014 events4 affected246 at risk
Chest pain	General disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Chills	General disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected246 at risk
Drug resistance	General disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Fatigue	General disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
General physical health deterioration	General disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Infusion site extravasation	General disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Malaise	General disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Mucosal inflammation	General disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Multi-organ failure	General disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0016 events6 affected246 at risk
Non-cardiac chest pain	General disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Oedema due to cardiac disease	General disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Pyrexia	General disorders	MedDRA 16	Systematic Assessment	EG00029 events23 affected255 at risk EG00127 events26 affected246 at risk
Serositis	General disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Sudden death	General disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Hepatic vein occlusion	Hepatobiliary disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG0015 events5 affected246 at risk
Acute graft versus host disease	Immune system disorders	MedDRA 16	Systematic Assessment	EG00010 events9 affected255 at risk EG0017 events7 affected246 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA 16	Systematic Assessment	EG000120 events76 affected255 at risk EG001123 events76 affected246 at risk
Acute graft versus host disease in liver	Immune system disorders	MedDRA 16	Systematic Assessment	EG00030 events24 affected255 at risk EG00123 events18 affected246 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 16	Systematic Assessment	EG000171 events122 affected255 at risk EG001165 events118 affected246 at risk
Alloimmunisation	Immune system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Chronic graft versus host disease	Immune system disorders	MedDRA 16	Systematic Assessment	EG0005 events4 affected255 at risk EG0012 events2 affected246 at risk
Chronic graft versus host disease in intestine	Immune system disorders	MedDRA 16	Systematic Assessment	EG0007 events6 affected255 at risk EG0013 events3 affected246 at risk
Chronic graft versus host disease in liver	Immune system disorders	MedDRA 16	Systematic Assessment	EG0007 events7 affected255 at risk EG0013 events3 affected246 at risk
Chronic graft versus host disease in skin	Immune system disorders	MedDRA 16	Systematic Assessment	EG0005 events5 affected255 at risk EG0011 events1 affected246 at risk
Abdominal abscess	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Abscess intestinal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Acinetobacter bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Adenovirus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Anorectal cellulitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Appendicitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Aspergillosis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Atypical pneumonia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
BK virus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG0014 events4 affected246 at risk
Bacterial infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Bacterial sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0004 events3 affected255 at risk EG0013 events3 affected246 at risk
Brain abscess	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Bronchitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Bronchopneumonia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0004 events3 affected255 at risk EG0014 events4 affected246 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Catheter site infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Cellulitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0013 events3 affected246 at risk
Cerebral aspergillosis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Citrobacter sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0005 events5 affected255 at risk EG0012 events2 affected246 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0005 events4 affected255 at risk EG0013 events3 affected246 at risk
Corona virus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Cystitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Cystitis bacterial	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0013 events3 affected246 at risk
Cytomegalovirus gastritis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Cytomegalovirus gastroenteritis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0006 events6 affected255 at risk EG00110 events10 affected246 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG00011 events9 affected255 at risk EG00113 events11 affected246 at risk
Device related infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Device related sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0010 events0 affected246 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Diverticulitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Encephalitis cytomegalovirus	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Encephalitis herpes	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Encephalitis viral	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0003 events2 affected255 at risk EG0011 events1 affected246 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Epstein-Barr viraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Escherichia sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0014 events3 affected246 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Gangrene	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Gastroenteritis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Genital herpes	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Hepatic candidiasis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Herpes simplex	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Herpes zoster	Infections and infestations	MedDRA 16	Systematic Assessment	EG0007 events5 affected255 at risk EG0014 events4 affected246 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Human herpesvirus 6 infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Human polyomavirus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Infected skin ulcer	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Influenza	Infections and infestations	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0013 events3 affected246 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Lobar pneumonia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Localised infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Lung infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0003 events2 affected255 at risk EG0014 events4 affected246 at risk
Meningitis aseptic	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Oral candidiasis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Oral herpes	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Peritonitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pharyngitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events2 affected246 at risk
Pneumonia	Infections and infestations	MedDRA 16	Systematic Assessment	EG00018 events15 affected255 at risk EG00120 events19 affected246 at risk
Pneumonia adenoviral	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0013 events3 affected246 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pneumonia fungal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pneumonia herpes viral	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pneumonia legionella	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pneumonia viral	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Postoperative wound infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected246 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Pulmonary mycosis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Respiratory tract infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0015 events4 affected246 at risk
Sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG00023 events20 affected255 at risk EG00114 events14 affected246 at risk
Septic shock	Infections and infestations	MedDRA 16	Systematic Assessment	EG00010 events9 affected255 at risk EG00110 events10 affected246 at risk
Sialoadenitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Sinusitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0011 events1 affected246 at risk
Sinusitis fungal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Skin infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG0016 events5 affected246 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Systemic mycosis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0014 events4 affected246 at risk
Urinary tract infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected246 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Viral haemorrhagic cystitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Viral infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Blood stem cell transplant failure	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG0013 events3 affected246 at risk
Drug dose omission	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events1 affected246 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Transfusion microchimerism	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0010 events0 affected246 at risk
Blood bilirubin increased	Investigations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Computerised tomogram thorax abnormal	Investigations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Immunosuppressant drug level increased	Investigations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Liver function test abnormal	Investigations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Platelet count decreased	Investigations	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0013 events1 affected246 at risk
Transaminases increased	Investigations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Weight decreased	Investigations	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0013 events1 affected246 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG0014 events4 affected246 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected246 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0003 events1 affected255 at risk EG0010 events0 affected246 at risk
Acute lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0008 events6 affected255 at risk EG0015 events5 affected246 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0016 events6 affected246 at risk
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG00021 events18 affected255 at risk EG00122 events17 affected246 at risk
Adult T-cell lymphoma/leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected246 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Chloroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Chronic lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events2 affected246 at risk
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0014 events3 affected246 at risk
Leukaemic infiltration brain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Mycosis fungoides recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0015 events5 affected246 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Non-Hodgkin's lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Peripheral T-cell lymphoma unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0012 events2 affected246 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
T-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
T-cell type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Acute polyneuropathy	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Amnesia	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Brain oedema	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Coma	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Convulsion	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected246 at risk
Dizziness	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Encephalitis	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Encephalopathy	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Facial paresis	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Headache	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Memory impairment	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Migraine	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Neurological decompensation	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Paraplegia	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Syncope	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Confusional state	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Delirium	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Disorientation	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Mania	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Mental disorder	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG0002 events1 affected255 at risk EG0011 events1 affected246 at risk
Mental status changes	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected246 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Haematuria	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Renal colic	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Renal failure	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0006 events5 affected255 at risk EG0013 events3 affected246 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG00046 events41 affected255 at risk EG00138 events28 affected246 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Renal impairment	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Renal injury	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0006 events6 affected255 at risk EG0010 events0 affected246 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG0012 events2 affected246 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG0014 events3 affected246 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected246 at risk
Idiopathic pneumonia syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0002 events1 affected255 at risk EG0013 events3 affected246 at risk
Mediastinal mass	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Obliterative bronchiolitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected246 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0007 events7 affected255 at risk EG0011 events1 affected246 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected246 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00013 events11 affected255 at risk EG0018 events8 affected246 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected246 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0013 events1 affected246 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Appendicectomy	Surgical and medical procedures	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Central venous catheter removal	Surgical and medical procedures	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Colectomy	Surgical and medical procedures	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Donor leukocyte infusion	Surgical and medical procedures	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Drug therapy	Surgical and medical procedures	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Stem cell transplant	Surgical and medical procedures	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected246 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 16	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected246 at risk
Haematoma	Vascular disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Hypotension	Vascular disorders	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG0012 events2 affected246 at risk
Microangiopathy	Vascular disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 16	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected246 at risk
Thrombophlebitis	Vascular disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk
Venoocclusive disease	Vascular disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected246 at risk
Venous thrombosis	Vascular disorders	MedDRA 16	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected246 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG000160 events75 affected255 at risk EG001146 events66 affected246 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG00098 events92 affected255 at risk EG001101 events91 affected246 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG00056 events23 affected255 at risk EG00151 events20 affected246 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG00098 events65 affected255 at risk EG00199 events65 affected246 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG00019 events18 affected255 at risk EG00121 events21 affected246 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16	Systematic Assessment	EG000111 events48 affected255 at risk EG001131 events49 affected246 at risk
Tachycardia	Cardiac disorders	MedDRA 16	Systematic Assessment	EG00024 events22 affected255 at risk EG00128 events22 affected246 at risk
Conjunctivitis	Eye disorders	MedDRA 16	Systematic Assessment	EG00018 events17 affected255 at risk EG00112 events12 affected246 at risk
Dry eye	Eye disorders	MedDRA 16	Systematic Assessment	EG00039 events37 affected255 at risk EG00145 events42 affected246 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00011 events8 affected255 at risk EG00115 events13 affected246 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00022 events22 affected255 at risk EG00118 events15 affected246 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00083 events60 affected255 at risk EG00184 events62 affected246 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00037 events33 affected255 at risk EG00132 events26 affected246 at risk
Constipation	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG000128 events103 affected255 at risk EG001119 events90 affected246 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG000244 events167 affected255 at risk EG001242 events166 affected246 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00031 events25 affected255 at risk EG00135 events30 affected246 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00027 events25 affected255 at risk EG00135 events31 affected246 at risk
Gastritis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00019 events19 affected255 at risk EG00120 events19 affected246 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00017 events16 affected255 at risk EG00125 events24 affected246 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00026 events23 affected255 at risk EG00128 events27 affected246 at risk
Nausea	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG000261 events177 affected255 at risk EG001273 events178 affected246 at risk
Oral pain	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00017 events16 affected255 at risk EG00120 events19 affected246 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00020 events20 affected255 at risk EG00123 events20 affected246 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG00096 events69 affected255 at risk EG001105 events79 affected246 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16	Systematic Assessment	EG000178 events122 affected255 at risk EG001195 events125 affected246 at risk
Asthenia	General disorders	MedDRA 16	Systematic Assessment	EG00043 events34 affected255 at risk EG00139 events30 affected246 at risk
Catheter site pain	General disorders	MedDRA 16	Systematic Assessment	EG00023 events21 affected255 at risk EG00129 events22 affected246 at risk
Chills	General disorders	MedDRA 16	Systematic Assessment	EG00059 events44 affected255 at risk EG00146 events36 affected246 at risk
Fatigue	General disorders	MedDRA 16	Systematic Assessment	EG00080 events69 affected255 at risk EG00165 events58 affected246 at risk
Injection site erythema	General disorders	MedDRA 16	Systematic Assessment	EG0005 events5 affected255 at risk EG00172 events49 affected246 at risk
Injection site induration	General disorders	MedDRA 16	Systematic Assessment	EG0003 events3 affected255 at risk EG00157 events38 affected246 at risk
Injection site pain	General disorders	MedDRA 16	Systematic Assessment	EG00083 events47 affected255 at risk EG0011,053 events193 affected246 at risk
Injection site swelling	General disorders	MedDRA 16	Systematic Assessment	EG0004 events4 affected255 at risk EG00136 events24 affected246 at risk
Malaise	General disorders	MedDRA 16	Systematic Assessment	EG00011 events10 affected255 at risk EG00115 events15 affected246 at risk
Mucosal inflammation	General disorders	MedDRA 16	Systematic Assessment	EG000147 events101 affected255 at risk EG00194 events75 affected246 at risk
Oedema	General disorders	MedDRA 16	Systematic Assessment	EG00024 events21 affected255 at risk EG00139 events35 affected246 at risk
Oedema peripheral	General disorders	MedDRA 16	Systematic Assessment	EG00095 events69 affected255 at risk EG00188 events66 affected246 at risk
Pain	General disorders	MedDRA 16	Systematic Assessment	EG00034 events32 affected255 at risk EG00134 events27 affected246 at risk
Pyrexia	General disorders	MedDRA 16	Systematic Assessment	EG000195 events128 affected255 at risk EG001180 events123 affected246 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 16	Systematic Assessment	EG00023 events16 affected255 at risk EG00117 events13 affected246 at risk
Chronic graft versus host disease	Immune system disorders	MedDRA 16	Systematic Assessment	EG000109 events60 affected255 at risk EG001110 events62 affected246 at risk
Chronic graft versus host disease in intestine	Immune system disorders	MedDRA 16	Systematic Assessment	EG00028 events21 affected255 at risk EG00122 events20 affected246 at risk
Chronic graft versus host disease in liver	Immune system disorders	MedDRA 16	Systematic Assessment	EG00045 events35 affected255 at risk EG00143 events30 affected246 at risk
Chronic graft versus host disease in skin	Immune system disorders	MedDRA 16	Systematic Assessment	EG00051 events46 affected255 at risk EG00140 events37 affected246 at risk
Engraftment syndrome	Immune system disorders	MedDRA 16	Systematic Assessment	EG0009 events9 affected255 at risk EG00115 events13 affected246 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 16	Systematic Assessment	EG00020 events19 affected255 at risk EG00120 events20 affected246 at risk
BK virus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG00013 events13 affected255 at risk EG00115 events13 affected246 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG00016 events16 affected255 at risk EG00118 events17 affected246 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG00064 events51 affected255 at risk EG00168 events45 affected246 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG000141 events96 affected255 at risk EG001132 events87 affected246 at risk
Device related infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG00016 events16 affected255 at risk EG00118 events16 affected246 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG00015 events13 affected255 at risk EG00116 events15 affected246 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG00011 events11 affected255 at risk EG00120 events13 affected246 at risk
Folliculitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG00018 events14 affected255 at risk EG0018 events8 affected246 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16	Systematic Assessment	EG00014 events12 affected255 at risk EG00115 events15 affected246 at risk
Oral candidiasis	Infections and infestations	MedDRA 16	Systematic Assessment	EG00031 events27 affected255 at risk EG00118 events17 affected246 at risk
Oral herpes	Infections and infestations	MedDRA 16	Systematic Assessment	EG00018 events17 affected255 at risk EG00113 events8 affected246 at risk
Pneumonia	Infections and infestations	MedDRA 16	Systematic Assessment	EG00013 events13 affected255 at risk EG00113 events13 affected246 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 16	Systematic Assessment	EG00020 events17 affected255 at risk EG00123 events20 affected246 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16	Systematic Assessment	EG00036 events27 affected255 at risk EG00124 events22 affected246 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16	Systematic Assessment	EG00012 events10 affected255 at risk EG00117 events15 affected246 at risk
Alanine aminotransferase increased	Investigations	MedDRA 16	Systematic Assessment	EG00047 events31 affected255 at risk EG00166 events33 affected246 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 16	Systematic Assessment	EG00045 events30 affected255 at risk EG00149 events30 affected246 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 16	Systematic Assessment	EG00024 events17 affected255 at risk EG00123 events18 affected246 at risk
Blood bilirubin increased	Investigations	MedDRA 16	Systematic Assessment	EG00048 events23 affected255 at risk EG00143 events21 affected246 at risk
Blood creatinine increased	Investigations	MedDRA 16	Systematic Assessment	EG00042 events29 affected255 at risk EG00127 events22 affected246 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 16	Systematic Assessment	EG00024 events13 affected255 at risk EG00126 events15 affected246 at risk
Neutrophil count decreased	Investigations	MedDRA 16	Systematic Assessment	EG00070 events33 affected255 at risk EG00162 events28 affected246 at risk
Platelet count decreased	Investigations	MedDRA 16	Systematic Assessment	EG00083 events37 affected255 at risk EG00149 events28 affected246 at risk
Transaminases increased	Investigations	MedDRA 16	Systematic Assessment	EG00011 events10 affected255 at risk EG00119 events18 affected246 at risk
Weight decreased	Investigations	MedDRA 16	Systematic Assessment	EG00015 events15 affected255 at risk EG00115 events12 affected246 at risk
White blood cell count decreased	Investigations	MedDRA 16	Systematic Assessment	EG00065 events23 affected255 at risk EG00145 events24 affected246 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG000109 events91 affected255 at risk EG00189 events72 affected246 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00016 events13 affected255 at risk EG00131 events13 affected246 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG0008 events8 affected255 at risk EG00119 events17 affected246 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00014 events14 affected255 at risk EG00116 events11 affected246 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00090 events66 affected255 at risk EG00181 events54 affected246 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00040 events23 affected255 at risk EG00143 events30 affected246 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00014 events10 affected255 at risk EG00117 events15 affected246 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00043 events30 affected255 at risk EG00153 events24 affected246 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00058 events37 affected255 at risk EG00151 events28 affected246 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG000120 events83 affected255 at risk EG001140 events92 affected246 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG000157 events113 affected255 at risk EG001168 events113 affected246 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00042 events25 affected255 at risk EG00132 events26 affected246 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 16	Systematic Assessment	EG00030 events27 affected255 at risk EG00128 events24 affected246 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00030 events27 affected255 at risk EG00142 events30 affected246 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00039 events39 affected255 at risk EG00152 events44 affected246 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00014 events13 affected255 at risk EG00112 events10 affected246 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00025 events19 affected255 at risk EG00115 events14 affected246 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00015 events14 affected255 at risk EG00110 events10 affected246 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00014 events14 affected255 at risk EG00121 events19 affected246 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00022 events19 affected255 at risk EG00123 events19 affected246 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00010 events10 affected255 at risk EG00118 events16 affected246 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16	Systematic Assessment	EG00031 events30 affected255 at risk EG00137 events32 affected246 at risk
Dizziness	Nervous system disorders	MedDRA 16	Systematic Assessment	EG00038 events33 affected255 at risk EG00144 events33 affected246 at risk
Dysgeusia	Nervous system disorders	MedDRA 16	Systematic Assessment	EG00022 events22 affected255 at risk EG00124 events23 affected246 at risk
Headache	Nervous system disorders	MedDRA 16	Systematic Assessment	EG000153 events103 affected255 at risk EG001150 events103 affected246 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 16	Systematic Assessment	EG00017 events17 affected255 at risk EG00117 events14 affected246 at risk
Tremor	Nervous system disorders	MedDRA 16	Systematic Assessment	EG00049 events46 affected255 at risk EG00124 events23 affected246 at risk
Anxiety	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG00053 events44 affected255 at risk EG00142 events40 affected246 at risk
Depression	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG00018 events18 affected255 at risk EG00111 events11 affected246 at risk
Insomnia	Psychiatric disorders	MedDRA 16	Systematic Assessment	EG00085 events76 affected255 at risk EG00186 events72 affected246 at risk
Dysuria	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG00033 events29 affected255 at risk EG00125 events20 affected246 at risk
Haematuria	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG00015 events15 affected255 at risk EG0018 events7 affected246 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG00016 events14 affected255 at risk EG0019 events8 affected246 at risk
Renal failure	Renal and urinary disorders	MedDRA 16	Systematic Assessment	EG00017 events16 affected255 at risk EG00119 events17 affected246 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00071 events60 affected255 at risk EG00171 events55 affected246 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00053 events44 affected255 at risk EG00150 events40 affected246 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00028 events23 affected255 at risk EG00137 events34 affected246 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00021 events20 affected255 at risk EG00124 events22 affected246 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00012 events10 affected255 at risk EG00121 events17 affected246 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00020 events18 affected255 at risk EG0018 events8 affected246 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00042 events41 affected255 at risk EG00133 events30 affected246 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16	Systematic Assessment	EG00017 events16 affected255 at risk EG00119 events18 affected246 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG00032 events30 affected255 at risk EG00131 events29 affected246 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG00020 events20 affected255 at risk EG00126 events25 affected246 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG00037 events28 affected255 at risk EG00150 events34 affected246 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG00085 events67 affected255 at risk EG00167 events59 affected246 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG00061 events52 affected255 at risk EG00167 events51 affected246 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 16	Systematic Assessment	EG00017 events13 affected255 at risk EG00115 events12 affected246 at risk
Hypertension	Vascular disorders	MedDRA 16	Systematic Assessment	EG00096 events83 affected255 at risk EG00178 events66 affected246 at risk
Hypotension	Vascular disorders	MedDRA 16	Systematic Assessment	EG00037 events36 affected255 at risk EG00150 events39 affected246 at risk

ID	Title	Description
BG000	Placebo	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
BG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
BG002	Total	Total of all reporting 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	Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).	100	255	221	255	254	255
EG001	ASP0113 5mg	Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).	105	246	221	246	244	246