Study of US-ATG-F to Prevent Chronic Graft Versus Host Di... | NCT01295710

Label	Type	Description	Intervention Names
US-ATG-F	Active Comparator	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation	Biological: US-ATG-F
Placebo	Placebo Comparator	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
US-ATG-F	Biological	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation	US-ATG-F

Measure	Description	Time Frame
Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD According to 2005 NIH Criteria as Determined by the Independent Endpoint Committee or Death From Any Cause After Allogeneic Stem Cell Transplantation	Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD, or death from any cause	Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, or death from any cause, assessed up to 48 months

Measure	Description	Time Frame
Overall Survival	Incidence of death from any cause	Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months
Number of Participants With Chronic GVHD Mild to Severe

Name	Affiliation	Role
Anne Kuan	Neovii Biotech	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope		Duarte	California	91019	United States
Stanford University Medical Center, BMT

PubMed Identifier	Type	Citation	Retractions
37341189	Derived	Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.

ID	Title	Description
FG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
FG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

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

Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD According to 2005 NIH Criteria as Determined by the Independent Endpoint Committee or Death From Any Cause After Allogeneic Stem Cell Transplantation

Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD, or death from any cause

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, or death from any cause, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000126 OG001128

Title

Denominators

Categories

Title	Measurements
	OG00060 OG00172

Secondary

Overall Survival

Incidence of death from any cause

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Chronic GVHD Mild to Severe

Participants with the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Chronic GVHD Moderate to Severe

Participants with the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Chronic GVHD Severe

Participants with the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Acute GVHD Grade I-IV

Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Acute GVHD Grade II-IV

Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Acute GVHD Grade III-IV

Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Relapse

Participants with relapse or disease recurrence, with death as competing risk

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Disease-free Survival

Incidence of relapse or death

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Transplant Related Mortality

Participants with transplant related mortality

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Secondary

Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD

Participants who started on systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks

Posted

Count of Participants

Participants

Time from first study drug administration until start of systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Number of Participants With First Occurrence of Moderate or Severe Chronic GVHD According to 2005 NIH Criteria as Determined by Principal Investigator or Death From Any Cause After Allogeneic Stem Cell Transplantation

Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD or death

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators or death from any cause, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants

Post-Hoc

Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS)

Participants with moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Grade III-IV Acute GVHD-free, GRFS

Participants with grade III-IV acute GVHD as determined by the Investigator, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of grade III-IV acute GVHD, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD or Death From Any Cause by Conditioning Regimen

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts

Post-Hoc

Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS) by Conditioning Regimen

Participants with moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants

Post-Hoc

Grade III-IV Acute GVHD-free GRFS by Conditioning Regimen

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants

Post-Hoc

Overall Survival by Conditioning Regimen

Incidence of death from any cause. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Chronic GVHD Mild to Severe by Conditioning Regimen

Participants with the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants

Post-Hoc

Chronic GVHD Moderate to Severe by Conditioning Regimen

Participants with the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants

Post-Hoc

Chronic GVHD Severe by Conditioning Regimen

Participants with the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Acute GVHD Grade I-IV by Conditioning Regimen

Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of acute GVHD grade I-IV, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Acute GVHD Grade II-IV by Conditioning Regimen

Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of acute GVHD grade II-IV, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Acute GVHD Grade III-IV by Conditioning Regimen

Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

Time from first study drug administration until the first occurrence of acute GVHD grade III-IV, with death and re transplantation as competing risks, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Relapse by Conditioning Regimen

Participants with relapse or disease recurrence, with death as competing risk. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of relapse with death as competing risk, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Disease-free Survival by Conditioning Regimen

Incidence of relapse or death. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Post-Hoc

Transplant-related Mortality by Conditioning Regimen

Participants with transplant related mortality. Analysis was conducted by conditioning regimen.

Analysis of patients who received a specific conditioning regimen

Posted

Count of Participants

Participants

Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months

ID	Title	Description
OG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
OG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Anaemia haemolytic autoimmune	Blood and lymphatic system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Febrile neutropenia	Blood and lymphatic system disorders	EG00011 events11 affected126 at risk EG0016 events6 affected128 at risk
Haemolysis	Blood and lymphatic system disorders	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Idiopathic thrombocytopenic purpura	Blood and lymphatic system disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Leukocytosis	Blood and lymphatic system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Microangiopathic haemolytic anaemia	Blood and lymphatic system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Neutropenia	Blood and lymphatic system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pancytopenia	Blood and lymphatic system disorders	EG0006 events6 affected126 at risk EG0014 events3 affected128 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0004 events4 affected126 at risk EG0010 events0 affected128 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Acute myocardial infarction	Cardiac disorders	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Angina pectoris	Cardiac disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Atrial fibrillation	Cardiac disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Cardiac arrest	Cardiac disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Cardio-respiratory arrest	Cardiac disorders	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Cardiopulmonary failure	Cardiac disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Myocardial infarction	Cardiac disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Myocardial ischaemia	Cardiac disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Myopericarditis	Cardiac disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Postural orthostatic tachycardia syndrome	Cardiac disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pulseless electrical activity	Cardiac disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Tachycardia	Cardiac disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Pupils unequal	Eye disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Abdominal discomfort	Gastrointestinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Abdominal pain	Gastrointestinal disorders	EG0003 events2 affected126 at risk EG0012 events2 affected128 at risk
Constipation	Gastrointestinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Diarrhoea	Gastrointestinal disorders	EG0009 events7 affected126 at risk EG0018 events7 affected128 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	EG0006 events6 affected126 at risk EG0010 events0 affected128 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Gastropleural fistula	Gastrointestinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Haematemesis	Gastrointestinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Impaired gastric emptying	Gastrointestinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Nausea	Gastrointestinal disorders	EG00010 events8 affected126 at risk EG0017 events7 affected128 at risk
Oral pain	Gastrointestinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Pancreatitis acute	Gastrointestinal disorders	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Peritonitis	Gastrointestinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Stomatitis	Gastrointestinal disorders	EG0002 events2 affected126 at risk EG0011 events1 affected128 at risk
Vomiting	Gastrointestinal disorders	EG0008 events8 affected126 at risk EG0018 events8 affected128 at risk
Asthenia	General disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Chills	General disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Fatigue	General disorders	EG0004 events2 affected126 at risk EG0011 events1 affected128 at risk
Mucosal haemorrhage	General disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Mucosal inflammation	General disorders	EG0004 events4 affected126 at risk EG0015 events5 affected128 at risk
Multi-organ failure	General disorders	EG0005 events5 affected126 at risk EG0011 events1 affected128 at risk
Oedema	General disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pain	General disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Pyrexia	General disorders	EG00014 events13 affected126 at risk EG00120 events15 affected128 at risk
Cholecystitis	Hepatobiliary disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Cholecystitis acute	Hepatobiliary disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Cholecystitis chronic	Hepatobiliary disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Cholelithiasis	Hepatobiliary disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Cholestasis	Hepatobiliary disorders	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Hepatic failure	Hepatobiliary disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Portal hypertension	Hepatobiliary disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Venoocclusive liver disease	Hepatobiliary disorders	EG0006 events6 affected126 at risk EG0011 events1 affected128 at risk
Acute graft versus host disease	Immune system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Acute graft versus host disease in intestine	Immune system disorders	EG0002 events1 affected126 at risk EG0013 events3 affected128 at risk
Chronic graft versus host disease	Immune system disorders	EG0000 events0 affected126 at risk EG0013 events3 affected128 at risk
Cytokine release syndrome	Immune system disorders	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Engraftment syndrome	Immune system disorders	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Graft versus host disease	Immune system disorders	EG0002 events2 affected126 at risk EG0015 events5 affected128 at risk
Graft versus host disease in lung	Immune system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Serum sickness	Immune system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Adenovirus infection	Infections and infestations	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Appendicitis	Infections and infestations	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Arthritis bacterial	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Bacteraemia	Infections and infestations	EG0004 events3 affected126 at risk EG0014 events4 affected128 at risk
Bacterial infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Bacterial sepsis	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Bronchitis	Infections and infestations	EG0003 events2 affected126 at risk EG0010 events0 affected128 at risk
Candidiasis	Infections and infestations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Cellulitis	Infections and infestations	EG0004 events3 affected126 at risk EG0014 events4 affected128 at risk
Clostridial infection	Infections and infestations	EG0002 events2 affected126 at risk EG0015 events5 affected128 at risk
Clostridium difficile colitis	Infections and infestations	EG0001 events1 affected126 at risk EG0013 events2 affected128 at risk
Corona virus infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Cystitis viral	Infections and infestations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Cytomegalovirus colitis	Infections and infestations	EG0001 events1 affected126 at risk EG0012 events1 affected128 at risk
Cytomegalovirus infection	Infections and infestations	EG0004 events4 affected126 at risk EG0010 events0 affected128 at risk
Cytomegalovirus viraemia	Infections and infestations	EG0001 events1 affected126 at risk EG0014 events4 affected128 at risk
Encephalitis fungal	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Encephalitis herpes	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Enterobacter bacteraemia	Infections and infestations	EG0003 events2 affected126 at risk EG0010 events0 affected128 at risk
Enterococcal bacteraemia	Infections and infestations	EG0003 events3 affected126 at risk EG0011 events1 affected128 at risk
Enterococcal infection	Infections and infestations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Enterocolitis infectious	Infections and infestations	EG0004 events3 affected126 at risk EG0011 events1 affected128 at risk
Epstein-Barr virus infection	Infections and infestations	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Escherichia bacteraemia	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Escherichia sepsis	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Fungal abscess central nervous system	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Fungal infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Fusobacterium infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Gastroenteritis	Infections and infestations	EG0003 events2 affected126 at risk EG0011 events1 affected128 at risk
H1N1 influenza	Infections and infestations	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Herpes zoster	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Infection	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Influenza	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Klebsiella infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Lobar pneumonia	Infections and infestations	EG0000 events0 affected126 at risk EG0012 events1 affected128 at risk
Lung infection	Infections and infestations	EG0001 events1 affected126 at risk EG0013 events3 affected128 at risk
Lung infection pseudomonal	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Oral herpes	Infections and infestations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Parainfluenzae virus infection	Infections and infestations	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pneumonia	Infections and infestations	EG0009 events8 affected126 at risk EG00122 events14 affected128 at risk
Pneumonia bacterial	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Pneumonia cytomegaloviral	Infections and infestations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Pneumonia haemophilus	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pneumonia legionella	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	EG0002 events2 affected126 at risk EG0014 events4 affected128 at risk
Pneumonia staphylococcal	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pneumonia streptococcal	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pneumonia viral	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pseudomonal bacteraemia	Infections and infestations	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Pyothorax	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Respiratory syncytial virus infection	Infections and infestations	EG0002 events2 affected126 at risk EG0011 events1 affected128 at risk
Rhinovirus infection	Infections and infestations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Sepsis	Infections and infestations	EG0006 events5 affected126 at risk EG00113 events13 affected128 at risk
Septic shock	Infections and infestations	EG0001 events1 affected126 at risk EG0014 events4 affected128 at risk
Sinusitis	Infections and infestations	EG0001 events1 affected126 at risk EG0012 events2 affected128 at risk
Sinusitis bacterial	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Skin infection	Infections and infestations	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Staphylococcal bacteraemia	Infections and infestations	EG0005 events5 affected126 at risk EG0010 events0 affected128 at risk
Staphylococcal infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Staphylococcal sepsis	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Streptococcal bacteraemia	Infections and infestations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Systemic candida	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Systemic mycosis	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Upper respiratory fungal infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Urinary tract infection	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Urinary tract infection bacterial	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Urinary tract infection viral	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Viraemia	Infections and infestations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Viral haemorrhagic cystitis	Infections and infestations	EG0004 events3 affected126 at risk EG0010 events0 affected128 at risk
Zygomycosis	Infections and infestations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Delayed engraftment	Injury, poisoning and procedural complications	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Foot fracture	Injury, poisoning and procedural complications	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Hepatic haematoma	Injury, poisoning and procedural complications	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Hip fracture	Injury, poisoning and procedural complications	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Infusion related reaction	Injury, poisoning and procedural complications	EG0006 events6 affected126 at risk EG0010 events0 affected128 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Pubis fracture	Injury, poisoning and procedural complications	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Splenic rupture	Injury, poisoning and procedural complications	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Subdural haematoma	Injury, poisoning and procedural complications	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Transfusion related complication	Injury, poisoning and procedural complications	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Transplant failure	Injury, poisoning and procedural complications	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Alanine aminotransferase increased	Investigations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Aspartate aminotransferase increased	Investigations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Blood bilirubin increased	Investigations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Clostridium test positive	Investigations	EG0000 events0 affected126 at risk EG0013 events3 affected128 at risk
Hepatic enzyme abnormal	Investigations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Hepatic enzyme increased	Investigations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Human rhinovirus test positive	Investigations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Legionella test positive	Investigations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Liver function test abnormal	Investigations	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Polyomavirus test positive	Investigations	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Respiratory rate increased	Investigations	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Respiratory syncytial virus test positive	Investigations	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Weight decreased	Investigations	EG0003 events2 affected126 at risk EG0010 events0 affected128 at risk
Decreased appetite	Metabolism and nutrition disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Dehydration	Metabolism and nutrition disorders	EG0002 events2 affected126 at risk EG0012 events2 affected128 at risk
Diabetes mellitus	Metabolism and nutrition disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Failure to thrive	Metabolism and nutrition disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Fluid overload	Metabolism and nutrition disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0001 events1 affected126 at risk EG0012 events2 affected128 at risk
Hyperkalaemia	Metabolism and nutrition disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Groin pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	EG0003 events3 affected126 at risk EG0011 events1 affected128 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Myositis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Acute lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0004 events4 affected126 at risk EG0011 events1 affected128 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 events2 affected126 at risk EG0011 events1 affected128 at risk
Acute myeloid leukemia, recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG00014 events14 affected126 at risk EG0015 events5 affected128 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Epstein-Barr virus associated lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0004 events4 affected126 at risk EG0010 events0 affected128 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 events2 affected126 at risk EG0012 events2 affected128 at risk
Somnolence	Nervous system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Acute disseminated encephalomyelitis	Nervous system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Aphasia	Nervous system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Cerebral haemorrhage	Nervous system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Cerebral infarction	Nervous system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Cerebrovascular accident	Nervous system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Coma	Nervous system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Convulsion	Nervous system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Dizziness	Nervous system disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Encephalitis	Nervous system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Headache	Nervous system disorders	EG0003 events2 affected126 at risk EG0011 events1 affected128 at risk
Myelitis transverse	Nervous system disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Optic neuritis	Nervous system disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Syncope	Nervous system disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Completed suicide	Psychiatric disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Confusional state	Psychiatric disorders	EG0004 events4 affected126 at risk EG0011 events1 affected128 at risk
Delirium	Psychiatric disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Depression	Psychiatric disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Mental status changes	Psychiatric disorders	EG0000 events0 affected126 at risk EG0016 events5 affected128 at risk
Psychotic disorder	Psychiatric disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Cystitis haemorrhagic	Renal and urinary disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Haematuria	Renal and urinary disorders	EG0001 events1 affected126 at risk EG0012 events2 affected128 at risk
Hydronephrosis	Renal and urinary disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Renal failure	Renal and urinary disorders	EG0001 events1 affected126 at risk EG0012 events2 affected128 at risk
Renal failure acute	Renal and urinary disorders	EG0006 events6 affected126 at risk EG0014 events4 affected128 at risk
Renal tubular necrosis	Renal and urinary disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected126 at risk EG0013 events3 affected128 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected126 at risk EG0015 events5 affected128 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0013 events2 affected128 at risk
Idiopathic pneumonia syndrome	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0013 events3 affected128 at risk
Obliterative bronchiolitis	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0012 events2 affected128 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0011 events1 affected128 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected126 at risk EG0011 events1 affected128 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected126 at risk EG0010 events0 affected128 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected126 at risk EG0012 events2 affected128 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0005 events5 affected126 at risk EG0013 events3 affected128 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Angioedema	Skin and subcutaneous tissue disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Rash	Skin and subcutaneous tissue disorders	EG0001 events1 affected126 at risk EG0010 events0 affected128 at risk
Deep vein thrombosis	Vascular disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Embolism	Vascular disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Hypotension	Vascular disorders	EG0007 events7 affected126 at risk EG0012 events2 affected128 at risk
Jugular vein thrombosis	Vascular disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk
Orthostatic hypotension	Vascular disorders	EG0000 events0 affected126 at risk EG0011 events1 affected128 at risk

ID	Term
D015470	Leukemia, Myeloid, Acute
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D009190	Myelodysplastic Syndromes
D000754	Anemia, Refractory, with Excess of Blasts

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D001855	Bone Marrow Diseases
D000753	Anemia, Refractory
D000740	Anemia

ID	Title	Description
BG000	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
BG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
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	US-ATG-F	20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation			98	126	125	126
EG001	Placebo	250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation			90	128	126	128

Term	Organ System	Statistical Information
Nausea	Gastrointestinal disorders	EG00063 events54 affected126 at risk EG00156 events47 affected128 at risk
Vomiting	Gastrointestinal disorders	EG00043 events38 affected126 at risk EG00127 events24 affected128 at risk
Diarrhoea	Gastrointestinal disorders	EG00045 events36 affected126 at risk EG00128 events22 affected128 at risk
Stomatitis	Gastrointestinal disorders	EG00026 events25 affected126 at risk EG00126 events26 affected128 at risk
Abdominal pain	Gastrointestinal disorders	EG00011 events11 affected126 at risk EG0014 events4 affected128 at risk
Dyspepsia	Gastrointestinal disorders	EG0003 events3 affected126 at risk EG00111 events11 affected128 at risk
Constipation	Gastrointestinal disorders	EG0002 events2 affected126 at risk EG0018 events8 affected128 at risk
Mucosal inflammation	General disorders	EG00044 events41 affected126 at risk EG00147 events41 affected128 at risk
Pyrexia	General disorders	EG00071 events57 affected126 at risk EG0012 events1 affected128 at risk
Fatigue	General disorders	EG00036 events33 affected126 at risk EG00134 events34 affected128 at risk
Chills	General disorders	EG00054 events50 affected126 at risk EG0017 events7 affected128 at risk
Oedema peripheral	General disorders	EG00011 events11 affected126 at risk EG0013 events3 affected128 at risk
Pain	General disorders	EG00010 events10 affected126 at risk EG0016 events2 affected128 at risk
Cytomegalovirus infection	Infections and infestations	EG00016 events12 affected126 at risk EG00120 events18 affected128 at risk
Cytomegalovirus viraemia	Infections and infestations	EG00019 events13 affected126 at risk EG00112 events10 affected128 at risk
Epstein-Barr virus infection	Infections and infestations	EG00016 events14 affected126 at risk EG0017 events6 affected128 at risk
Clostridial infection	Infections and infestations	EG0007 events5 affected126 at risk EG0018 events7 affected128 at risk
Clostridium difficile colitis	Infections and infestations	EG00013 events11 affected126 at risk EG0013 events2 affected128 at risk
Staphylococcal bacteraemia	Infections and infestations	EG00013 events9 affected126 at risk EG0011 events1 affected128 at risk
Urinary tract infection	Infections and infestations	EG0009 events9 affected126 at risk EG0013 events3 affected128 at risk
Epstein-Barr viraemia	Infections and infestations	EG0008 events8 affected126 at risk EG0011 events1 affected128 at risk
Febrile neutropenia	Blood and lymphatic system disorders	EG00044 events34 affected126 at risk EG00148 events47 affected128 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG00042 events22 affected126 at risk EG00129 events12 affected128 at risk
Anaemia	Blood and lymphatic system disorders	EG00027 events14 affected126 at risk EG00121 events11 affected128 at risk
Neutropenia	Blood and lymphatic system disorders	EG00022 events12 affected126 at risk EG00110 events8 affected128 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00022 events22 affected126 at risk EG0016 events5 affected128 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG00012 events11 affected126 at risk EG0012 events1 affected128 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0007 events7 affected126 at risk EG0010 events0 affected128 at risk
White blood cell count decreased	Investigations	EG00015 events9 affected126 at risk EG0019 events5 affected128 at risk
Blood bilirubin increased	Investigations	EG00014 events9 affected126 at risk EG0013 events2 affected128 at risk
Epstein-Barr virus test positive	Investigations	EG0007 events7 affected126 at risk EG0013 events1 affected128 at risk
Headache	Nervous system disorders	EG00044 events38 affected126 at risk EG00122 events19 affected128 at risk
Dizziness	Nervous system disorders	EG00010 events8 affected126 at risk EG0012 events2 affected128 at risk
Rash	Skin and subcutaneous tissue disorders	EG00035 events31 affected126 at risk EG0017 events7 affected128 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	EG0007 events7 affected126 at risk EG0011 events1 affected128 at risk
Hypotension	Vascular disorders	EG00036 events32 affected126 at risk EG0017 events6 affected128 at risk
Hypertension	Vascular disorders	EG00017 events16 affected126 at risk EG0016 events6 affected128 at risk
Flushing	Vascular disorders	EG0009 events9 affected126 at risk EG0012 events2 affected128 at risk
Tachycardia	Cardiac disorders	EG00024 events23 affected126 at risk EG0013 events3 affected128 at risk
Sinus tachycardia	Cardiac disorders	EG00019 events19 affected126 at risk EG0018 events5 affected128 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG00010 events10 affected126 at risk EG0019 events7 affected128 at risk
Decreased appetite	Metabolism and nutrition disorders	EG0007 events7 affected126 at risk EG0016 events6 affected128 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	EG0008 events8 affected126 at risk EG0011 events1 affected128 at risk
Anxiety	Psychiatric disorders	EG00013 events13 affected126 at risk EG0016 events6 affected128 at risk
Infusion related reaction	Injury, poisoning and procedural complications	EG00030 events16 affected126 at risk EG0016 events4 affected128 at risk