Trial Outcomes & Findings for Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD) (NCT NCT01295710)
NCT ID: NCT01295710
Last Updated: 2019-04-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
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
Results posted on
2019-04-09
Participant Flow
The Enrollment number of 260 participants in the Protocol Section represents the number of patients who were randomized. The number of 254 participants who Started in the Participant Flow module represents the number of patients who were randomized and were treated.
Participant milestones
| Measure |
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
|
Placebo
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
128
|
|
Overall Study
COMPLETED
|
48
|
78
|
|
Overall Study
NOT COMPLETED
|
78
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis of patients who received a specific conditioning regimen
Baseline characteristics by cohort
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 years to ≤40 years
|
42 Participants
n=126 Participants
|
43 Participants
n=128 Participants
|
85 Participants
n=254 Participants
|
|
Age, Customized
>40 years to 65 years
|
84 Participants
n=126 Participants
|
85 Participants
n=128 Participants
|
169 Participants
n=254 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=126 Participants
|
49 Participants
n=128 Participants
|
115 Participants
n=254 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=126 Participants
|
79 Participants
n=128 Participants
|
139 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=126 Participants
|
6 Participants
n=128 Participants
|
11 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=126 Participants
|
117 Participants
n=128 Participants
|
236 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=126 Participants
|
5 Participants
n=128 Participants
|
7 Participants
n=254 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=126 Participants
|
1 Participants
n=128 Participants
|
1 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=126 Participants
|
1 Participants
n=128 Participants
|
3 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=126 Participants
|
0 Participants
n=128 Participants
|
0 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=126 Participants
|
4 Participants
n=128 Participants
|
4 Participants
n=254 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=126 Participants
|
117 Participants
n=128 Participants
|
234 Participants
n=254 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=126 Participants
|
1 Participants
n=128 Participants
|
1 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=126 Participants
|
4 Participants
n=128 Participants
|
11 Participants
n=254 Participants
|
|
Region of Enrollment
United States
|
124 Participants
n=126 Participants
|
125 Participants
n=128 Participants
|
249 Participants
n=254 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=126 Participants
|
3 Participants
n=128 Participants
|
5 Participants
n=254 Participants
|
|
Disease
Acute lymphoid leukemia (ALL)
|
23 Participants
n=126 Participants
|
34 Participants
n=128 Participants
|
57 Participants
n=254 Participants
|
|
Disease
Myelodysplastic syndrome (MDS)
|
19 Participants
n=126 Participants
|
14 Participants
n=128 Participants
|
33 Participants
n=254 Participants
|
|
Disease
Acute myeloid leukemia (AML)
|
83 Participants
n=126 Participants
|
80 Participants
n=128 Participants
|
163 Participants
n=254 Participants
|
|
Disease
Biphenotypic AML/ALL
|
1 Participants
n=126 Participants
|
0 Participants
n=128 Participants
|
1 Participants
n=254 Participants
|
|
Source of stem cells
Bone marrow
|
22 Participants
n=126 Participants
|
27 Participants
n=128 Participants
|
49 Participants
n=254 Participants
|
|
Source of stem cells
Peripheral blood
|
95 Participants
n=126 Participants
|
101 Participants
n=128 Participants
|
196 Participants
n=254 Participants
|
|
Source of stem cells
No stem cell transplantation
|
9 Participants
n=126 Participants
|
0 Participants
n=128 Participants
|
9 Participants
n=254 Participants
|
|
Conditioning regimen
Cyclophosphamide & total body irradiation (CY-TBI)
|
31 Participants
n=126 Participants
|
37 Participants
n=128 Participants
|
68 Participants
n=254 Participants
|
|
Conditioning regimen
Busulfan & cyclophosphamide (BU-CY)
|
47 Participants
n=126 Participants
|
37 Participants
n=128 Participants
|
84 Participants
n=254 Participants
|
|
Conditioning regimen
Fludarabine & busulfan (FLU-BU)
|
48 Participants
n=126 Participants
|
54 Participants
n=128 Participants
|
102 Participants
n=254 Participants
|
|
ALC at Study Day -3 Overall Study
ALC ≤ 0.1 x 10^9 lymphocytes/L
|
51 Participants
n=126 Participants
|
41 Participants
n=128 Participants
|
92 Participants
n=254 Participants
|
|
ALC at Study Day -3 Overall Study
ALC > 0.1 x 10^9 lymphocytes/L
|
64 Participants
n=126 Participants
|
74 Participants
n=128 Participants
|
138 Participants
n=254 Participants
|
|
ALC at Study Day -3 Overall Study
Not tested
|
11 Participants
n=126 Participants
|
13 Participants
n=128 Participants
|
24 Participants
n=254 Participants
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: CY-TBI · ALC ≤ 0.1 x 10^9 lymphocytes/L
|
22 Participants
n=31 Participants • Analysis of patients who received a specific conditioning regimen
|
24 Participants
n=37 Participants • Analysis of patients who received a specific conditioning regimen
|
46 Participants
n=68 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: CY-TBI · ALC > 0.1 x 10^9 lymphocytes/L
|
7 Participants
n=31 Participants • Analysis of patients who received a specific conditioning regimen
|
11 Participants
n=37 Participants • Analysis of patients who received a specific conditioning regimen
|
18 Participants
n=68 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: CY-TBI · Not tested
|
2 Participants
n=31 Participants • Analysis of patients who received a specific conditioning regimen
|
2 Participants
n=37 Participants • Analysis of patients who received a specific conditioning regimen
|
4 Participants
n=68 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: BU-CY · ALC ≤ 0.1 x 10^9 lymphocytes/L
|
6 Participants
n=47 Participants • Analysis of patients who received a specific conditioning regimen
|
2 Participants
n=37 Participants • Analysis of patients who received a specific conditioning regimen
|
8 Participants
n=84 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: BU-CY · ALC > 0.1 x 10^9 lymphocytes/L
|
39 Participants
n=47 Participants • Analysis of patients who received a specific conditioning regimen
|
31 Participants
n=37 Participants • Analysis of patients who received a specific conditioning regimen
|
70 Participants
n=84 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: BU-CY · Not tested
|
2 Participants
n=47 Participants • Analysis of patients who received a specific conditioning regimen
|
4 Participants
n=37 Participants • Analysis of patients who received a specific conditioning regimen
|
6 Participants
n=84 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: FLU-BU · ALC ≤ 0.1 x 10^9 lymphocytes/L
|
23 Participants
n=48 Participants • Analysis of patients who received a specific conditioning regimen
|
15 Participants
n=54 Participants • Analysis of patients who received a specific conditioning regimen
|
38 Participants
n=102 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: FLU-BU · ALC > 0.1 x 10^9 lymphocytes/L
|
18 Participants
n=48 Participants • Analysis of patients who received a specific conditioning regimen
|
32 Participants
n=54 Participants • Analysis of patients who received a specific conditioning regimen
|
50 Participants
n=102 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimen: FLU-BU · Not tested
|
7 Participants
n=48 Participants • Analysis of patients who received a specific conditioning regimen
|
7 Participants
n=54 Participants • Analysis of patients who received a specific conditioning regimen
|
14 Participants
n=102 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimens: BU-CY + FLU-BU · ALC ≤ 0.1 x 10^9 lymphocytes/L
|
29 Participants
n=95 Participants • Analysis of patients who received a specific conditioning regimen
|
17 Participants
n=91 Participants • Analysis of patients who received a specific conditioning regimen
|
46 Participants
n=186 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimens: BU-CY + FLU-BU · ALC > 0.1 x 10^9 lymphocytes/L
|
57 Participants
n=95 Participants • Analysis of patients who received a specific conditioning regimen
|
63 Participants
n=91 Participants • Analysis of patients who received a specific conditioning regimen
|
120 Participants
n=186 Participants • Analysis of patients who received a specific conditioning regimen
|
|
ALC at Study Day -3 by Conditioning Regimen
Regimens: BU-CY + FLU-BU · Not tested
|
9 Participants
n=95 Participants • Analysis of patients who received a specific conditioning regimen
|
11 Participants
n=91 Participants • Analysis of patients who received a specific conditioning regimen
|
20 Participants
n=186 Participants • Analysis of patients who received a specific conditioning regimen
|
PRIMARY outcome
Timeframe: 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 monthsParticipants 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
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
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
|
60 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 monthsIncidence of death from any cause
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Overall Survival
|
49 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 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 monthsParticipants 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
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Chronic GVHD Mild to Severe
|
18 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 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 monthsParticipants 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
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Chronic GVHD Moderate to Severe
|
13 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 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 monthsParticipants 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
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Chronic GVHD Severe
|
3 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 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 monthsParticipants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Acute GVHD Grade I-IV
|
48 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: 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 monthsParticipants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Acute GVHD Grade II-IV
|
28 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 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 monthsParticipants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Acute GVHD Grade III-IV
|
8 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 monthsParticipants with relapse or disease recurrence, with death as competing risk
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Relapse
|
37 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 monthsIncidence of relapse or death
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Disease-free Survival
|
61 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 monthsParticipants with transplant related mortality
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With Transplant Related Mortality
|
24 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 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 monthsParticipants 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
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD
|
8 Participants
|
33 Participants
|
POST_HOC outcome
Timeframe: 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 monthsParticipants 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
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
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
|
63 Participants
|
86 Participants
|
POST_HOC outcome
Timeframe: 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 monthsParticipants with moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS)
|
70 Participants
|
81 Participants
|
POST_HOC outcome
Timeframe: 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 monthsParticipants 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
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Grade III-IV Acute GVHD-free, GRFS
|
72 Participants
|
85 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific conditioning regimen
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. Analysis was conducted by conditioning regimen.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD or Death From Any Cause by Conditioning Regimen
Regimen: CY-TBI
|
20 Participants
|
16 Participants
|
|
Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD or Death From Any Cause by Conditioning Regimen
Regimen: BU-CY
|
18 Participants
|
21 Participants
|
|
Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD or Death From Any Cause by Conditioning Regimen
Regimen: FLU-BU
|
22 Participants
|
35 Participants
|
|
Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD or Death From Any Cause by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
40 Participants
|
56 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific 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.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS) by Conditioning Regimen
Regimen: CY-TBI
|
23 Participants
|
20 Participants
|
|
Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS) by Conditioning Regimen
Regimen: BU-CY
|
21 Participants
|
22 Participants
|
|
Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS) by Conditioning Regimen
Regimen: FLU-BU
|
26 Participants
|
39 Participants
|
|
Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS) by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
47 Participants
|
61 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific conditioning regimen
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. Analysis was conducted by conditioning regimen.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Grade III-IV Acute GVHD-free GRFS by Conditioning Regimen
Regimen: CY-TBI
|
23 Participants
|
21 Participants
|
|
Grade III-IV Acute GVHD-free GRFS by Conditioning Regimen
Regimen: BU-CY
|
23 Participants
|
22 Participants
|
|
Grade III-IV Acute GVHD-free GRFS by Conditioning Regimen
Regimen: FLU-BU
|
26 Participants
|
42 Participants
|
|
Grade III-IV Acute GVHD-free GRFS by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
49 Participants
|
64 Participants
|
POST_HOC outcome
Timeframe: Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 monthsPopulation: Analysis of patients who received a specific conditioning regimen
Incidence of death from any cause. Analysis was conducted by conditioning regimen.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Overall Survival by Conditioning Regimen
Regimen: CY-TBI
|
17 Participants
|
8 Participants
|
|
Overall Survival by Conditioning Regimen
Regimen: BU-CY
|
12 Participants
|
8 Participants
|
|
Overall Survival by Conditioning Regimen
Regimen: FLU-BU
|
20 Participants
|
20 Participants
|
|
Overall Survival by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
32 Participants
|
28 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific 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.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Chronic GVHD Mild to Severe by Conditioning Regimen
Regimen: CY-TBI
|
7 Participants
|
16 Participants
|
|
Chronic GVHD Mild to Severe by Conditioning Regimen
Regimen: BU-CY
|
6 Participants
|
14 Participants
|
|
Chronic GVHD Mild to Severe by Conditioning Regimen
Regimen: FLU-BU
|
5 Participants
|
20 Participants
|
|
Chronic GVHD Mild to Severe by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
11 Participants
|
34 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific 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.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Chronic GVHD Moderate to Severe by Conditioning Regimen
Regimen: CY-TBI
|
5 Participants
|
13 Participants
|
|
Chronic GVHD Moderate to Severe by Conditioning Regimen
Regimen: BU-CY
|
6 Participants
|
13 Participants
|
|
Chronic GVHD Moderate to Severe by Conditioning Regimen
Regimen: FLU-BU
|
2 Participants
|
19 Participants
|
|
Chronic GVHD Moderate to Severe by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
8 Participants
|
32 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific 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.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Chronic GVHD Severe by Conditioning Regimen
Regimen: CY-TBI
|
1 Participants
|
5 Participants
|
|
Chronic GVHD Severe by Conditioning Regimen
Regimen: BU-CY
|
1 Participants
|
4 Participants
|
|
Chronic GVHD Severe by Conditioning Regimen
Regimen: FLU-BU
|
1 Participants
|
7 Participants
|
|
Chronic GVHD Severe by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
2 Participants
|
11 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific 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.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Acute GVHD Grade I-IV by Conditioning Regimen
Regimen: BU-CY
|
19 Participants
|
23 Participants
|
|
Acute GVHD Grade I-IV by Conditioning Regimen
Regimen: FLU-BU
|
16 Participants
|
30 Participants
|
|
Acute GVHD Grade I-IV by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
35 Participants
|
53 Participants
|
|
Acute GVHD Grade I-IV by Conditioning Regimen
Regimen: CY-TBI
|
13 Participants
|
18 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific 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.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Acute GVHD Grade II-IV by Conditioning Regimen
Regimen: CY-TBI
|
8 Participants
|
14 Participants
|
|
Acute GVHD Grade II-IV by Conditioning Regimen
Regimen: BU-CY
|
12 Participants
|
17 Participants
|
|
Acute GVHD Grade II-IV by Conditioning Regimen
Regimen: FLU-BU
|
8 Participants
|
22 Participants
|
|
Acute GVHD Grade II-IV by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
20 Participants
|
39 Participants
|
POST_HOC outcome
Timeframe: 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 monthsPopulation: Analysis of patients who received a specific 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.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Acute GVHD Grade III-IV by Conditioning Regimen
Regimen: CY-TBI
|
3 Participants
|
2 Participants
|
|
Acute GVHD Grade III-IV by Conditioning Regimen
Regimen: BU-CY
|
4 Participants
|
5 Participants
|
|
Acute GVHD Grade III-IV by Conditioning Regimen
Regimen: FLU-BU
|
1 Participants
|
10 Participants
|
|
Acute GVHD Grade III-IV by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
5 Participants
|
15 Participants
|
POST_HOC outcome
Timeframe: Time from first study drug administration until the occurrence of relapse with death as competing risk, assessed up to 48 monthsPopulation: Analysis of patients who received a specific conditioning regimen
Participants with relapse or disease recurrence, with death as competing risk. Analysis was conducted by conditioning regimen.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Relapse by Conditioning Regimen
Regimen: CY-TBI
|
11 Participants
|
6 Participants
|
|
Relapse by Conditioning Regimen
Regimen: BU-CY
|
8 Participants
|
7 Participants
|
|
Relapse by Conditioning Regimen
Regimen: FLU-BU
|
18 Participants
|
13 Participants
|
|
Relapse by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
26 Participants
|
20 Participants
|
POST_HOC outcome
Timeframe: Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 monthsPopulation: Analysis of patients who received a specific conditioning regimen
Incidence of relapse or death. Analysis was conducted by conditioning regimen.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Disease-free Survival by Conditioning Regimen
Regimen: CY-TBI
|
21 Participants
|
13 Participants
|
|
Disease-free Survival by Conditioning Regimen
Regimen: BU-CY
|
15 Participants
|
11 Participants
|
|
Disease-free Survival by Conditioning Regimen
Regimen: FLU-BU
|
25 Participants
|
25 Participants
|
|
Disease-free Survival by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
40 Participants
|
36 Participants
|
POST_HOC outcome
Timeframe: Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 monthsPopulation: Analysis of patients who received a specific conditioning regimen
Participants with transplant related mortality. Analysis was conducted by conditioning regimen.
Outcome measures
| Measure |
US-ATG-F
n=126 Participants
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 Participants
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Transplant-related Mortality by Conditioning Regimen
Regimen: CY-TBI
|
10 Participants
|
7 Participants
|
|
Transplant-related Mortality by Conditioning Regimen
Regimen: BU-CY
|
7 Participants
|
4 Participants
|
|
Transplant-related Mortality by Conditioning Regimen
Regimen: FLU-BU
|
7 Participants
|
12 Participants
|
|
Transplant-related Mortality by Conditioning Regimen
Regimens: BU-CY + FLU-BU
|
14 Participants
|
16 Participants
|
Adverse Events
US-ATG-F
Serious events: 98 serious events
Other events: 125 other events
Deaths: 0 deaths
Placebo
Serious events: 90 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
US-ATG-F
n=126 participants at risk
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 participants at risk
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.7%
11/126 • Number of events 11
|
4.7%
6/128 • Number of events 6
|
|
Blood and lymphatic system disorders
Haemolysis
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.8%
6/126 • Number of events 6
|
2.3%
3/128 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
4/126 • Number of events 4
|
0.00%
0/128
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Cardiac disorders
Angina pectoris
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Cardiac disorders
Atrial fibrillation
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Eye disorders
Pupils unequal
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
2/126 • Number of events 3
|
1.6%
2/128 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
7/126 • Number of events 9
|
5.5%
7/128 • Number of events 8
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.8%
6/126 • Number of events 6
|
0.00%
0/128
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Gastrointestinal disorders
Gastropleural fistula
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.3%
8/126 • Number of events 10
|
5.5%
7/128 • Number of events 7
|
|
Gastrointestinal disorders
Oral pain
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
2/126 • Number of events 2
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.3%
8/126 • Number of events 8
|
6.2%
8/128 • Number of events 8
|
|
General disorders
Asthenia
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
General disorders
Chills
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
General disorders
Fatigue
|
1.6%
2/126 • Number of events 4
|
0.78%
1/128 • Number of events 1
|
|
General disorders
Mucosal haemorrhage
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
General disorders
Mucosal inflammation
|
3.2%
4/126 • Number of events 4
|
3.9%
5/128 • Number of events 5
|
|
General disorders
Multi-organ failure
|
4.0%
5/126 • Number of events 5
|
0.78%
1/128 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
General disorders
Pain
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
General disorders
Pyrexia
|
10.3%
13/126 • Number of events 14
|
11.7%
15/128 • Number of events 20
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Hepatobiliary disorders
Cholestasis
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
4.8%
6/126 • Number of events 6
|
0.78%
1/128 • Number of events 1
|
|
Immune system disorders
Acute graft versus host disease
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
0.79%
1/126 • Number of events 2
|
2.3%
3/128 • Number of events 3
|
|
Immune system disorders
Chronic graft versus host disease
|
0.00%
0/126
|
2.3%
3/128 • Number of events 3
|
|
Immune system disorders
Cytokine release syndrome
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Immune system disorders
Engraftment syndrome
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Immune system disorders
Graft versus host disease
|
1.6%
2/126 • Number of events 2
|
3.9%
5/128 • Number of events 5
|
|
Immune system disorders
Graft versus host disease in lung
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Immune system disorders
Serum sickness
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Adenovirus infection
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Infections and infestations
Appendicitis
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Infections and infestations
Arthritis bacterial
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Bacteraemia
|
2.4%
3/126 • Number of events 4
|
3.1%
4/128 • Number of events 4
|
|
Infections and infestations
Bacterial infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Bacterial sepsis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Bronchitis
|
1.6%
2/126 • Number of events 3
|
0.00%
0/128
|
|
Infections and infestations
Candidiasis
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
2.4%
3/126 • Number of events 4
|
3.1%
4/128 • Number of events 4
|
|
Infections and infestations
Clostridial infection
|
1.6%
2/126 • Number of events 2
|
3.9%
5/128 • Number of events 5
|
|
Infections and infestations
Clostridium difficile colitis
|
0.79%
1/126 • Number of events 1
|
1.6%
2/128 • Number of events 3
|
|
Infections and infestations
Corona virus infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Cystitis viral
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 2
|
|
Infections and infestations
Cytomegalovirus infection
|
3.2%
4/126 • Number of events 4
|
0.00%
0/128
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.79%
1/126 • Number of events 1
|
3.1%
4/128 • Number of events 4
|
|
Infections and infestations
Encephalitis fungal
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Encephalitis herpes
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Enterobacter bacteraemia
|
1.6%
2/126 • Number of events 3
|
0.00%
0/128
|
|
Infections and infestations
Enterococcal bacteraemia
|
2.4%
3/126 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Enterococcal infection
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Enterocolitis infectious
|
2.4%
3/126 • Number of events 4
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Epstein-Barr virus infection
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Infections and infestations
Escherichia bacteraemia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Escherichia sepsis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Fungal abscess central nervous system
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Fungal infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Fusobacterium infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/126 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Infections and infestations
Herpes zoster
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Infection
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Klebsiella infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/126
|
0.78%
1/128 • Number of events 2
|
|
Infections and infestations
Lung infection
|
0.79%
1/126 • Number of events 1
|
2.3%
3/128 • Number of events 3
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
6.3%
8/126 • Number of events 9
|
10.9%
14/128 • Number of events 22
|
|
Infections and infestations
Pneumonia bacterial
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Pneumonia legionella
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.6%
2/126 • Number of events 2
|
3.1%
4/128 • Number of events 4
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Infections and infestations
Pyothorax
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.6%
2/126 • Number of events 2
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Rhinovirus infection
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Sepsis
|
4.0%
5/126 • Number of events 6
|
10.2%
13/128 • Number of events 13
|
|
Infections and infestations
Septic shock
|
0.79%
1/126 • Number of events 1
|
3.1%
4/128 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
0.79%
1/126 • Number of events 1
|
1.6%
2/128 • Number of events 2
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Infections and infestations
Staphylococcal bacteraemia
|
4.0%
5/126 • Number of events 5
|
0.00%
0/128
|
|
Infections and infestations
Staphylococcal infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Staphylococcal sepsis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Systemic candida
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Systemic mycosis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Upper respiratory fungal infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Urinary tract infection viral
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Viraemia
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
2.4%
3/126 • Number of events 4
|
0.00%
0/128
|
|
Infections and infestations
Zygomycosis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Delayed engraftment
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.8%
6/126 • Number of events 6
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Transfusion related complication
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Investigations
Alanine aminotransferase increased
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Investigations
Aspartate aminotransferase increased
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Investigations
Blood bilirubin increased
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Investigations
Clostridium test positive
|
0.00%
0/126
|
2.3%
3/128 • Number of events 3
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Investigations
Human rhinovirus test positive
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Investigations
Legionella test positive
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Investigations
Polyomavirus test positive
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Investigations
Respiratory rate increased
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Investigations
Weight decreased
|
1.6%
2/126 • Number of events 3
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
2/126 • Number of events 2
|
1.6%
2/128 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.79%
1/126 • Number of events 1
|
1.6%
2/128 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
3/126 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
3.2%
4/126 • Number of events 4
|
0.78%
1/128 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.6%
2/126 • Number of events 2
|
0.78%
1/128 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia, recurrent
|
11.1%
14/126 • Number of events 14
|
3.9%
5/128 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoproliferative disorder
|
3.2%
4/126 • Number of events 4
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
1.6%
2/126 • Number of events 2
|
1.6%
2/128 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Acute disseminated encephalomyelitis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Aphasia
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Nervous system disorders
Coma
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Encephalitis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Nervous system disorders
Headache
|
1.6%
2/126 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Myelitis transverse
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
3.2%
4/126 • Number of events 4
|
0.78%
1/128 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/126
|
3.9%
5/128 • Number of events 6
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Renal and urinary disorders
Haematuria
|
0.79%
1/126 • Number of events 1
|
1.6%
2/128 • Number of events 2
|
|
Renal and urinary disorders
Hydronephrosis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Renal and urinary disorders
Renal failure
|
0.79%
1/126 • Number of events 1
|
1.6%
2/128 • Number of events 2
|
|
Renal and urinary disorders
Renal failure acute
|
4.8%
6/126 • Number of events 6
|
3.1%
4/128 • Number of events 4
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/126
|
2.3%
3/128 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
3/126 • Number of events 3
|
3.9%
5/128 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.79%
1/126 • Number of events 1
|
1.6%
2/128 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.79%
1/126 • Number of events 1
|
2.3%
3/128 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.79%
1/126 • Number of events 1
|
1.6%
2/128 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.79%
1/126 • Number of events 1
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
2/126 • Number of events 2
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.6%
2/126 • Number of events 2
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/126
|
1.6%
2/128 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
5/126 • Number of events 5
|
2.3%
3/128 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.79%
1/126 • Number of events 1
|
0.00%
0/128
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Vascular disorders
Embolism
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Vascular disorders
Hypotension
|
5.6%
7/126 • Number of events 7
|
1.6%
2/128 • Number of events 2
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/126
|
0.78%
1/128 • Number of events 1
|
Other adverse events
| Measure |
US-ATG-F
n=126 participants at risk
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
Placebo
n=128 participants at risk
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
42.9%
54/126 • Number of events 63
|
36.7%
47/128 • Number of events 56
|
|
Gastrointestinal disorders
Vomiting
|
30.2%
38/126 • Number of events 43
|
18.8%
24/128 • Number of events 27
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
36/126 • Number of events 45
|
17.2%
22/128 • Number of events 28
|
|
Gastrointestinal disorders
Stomatitis
|
19.8%
25/126 • Number of events 26
|
20.3%
26/128 • Number of events 26
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
11/126 • Number of events 11
|
3.1%
4/128 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
3/126 • Number of events 3
|
8.6%
11/128 • Number of events 11
|
|
Gastrointestinal disorders
Constipation
|
1.6%
2/126 • Number of events 2
|
6.2%
8/128 • Number of events 8
|
|
General disorders
Mucosal inflammation
|
32.5%
41/126 • Number of events 44
|
32.0%
41/128 • Number of events 47
|
|
General disorders
Pyrexia
|
45.2%
57/126 • Number of events 71
|
0.78%
1/128 • Number of events 2
|
|
General disorders
Fatigue
|
26.2%
33/126 • Number of events 36
|
26.6%
34/128 • Number of events 34
|
|
General disorders
Chills
|
39.7%
50/126 • Number of events 54
|
5.5%
7/128 • Number of events 7
|
|
General disorders
Oedema peripheral
|
8.7%
11/126 • Number of events 11
|
2.3%
3/128 • Number of events 3
|
|
General disorders
Pain
|
7.9%
10/126 • Number of events 10
|
1.6%
2/128 • Number of events 6
|
|
Infections and infestations
Cytomegalovirus infection
|
9.5%
12/126 • Number of events 16
|
14.1%
18/128 • Number of events 20
|
|
Infections and infestations
Cytomegalovirus viraemia
|
10.3%
13/126 • Number of events 19
|
7.8%
10/128 • Number of events 12
|
|
Infections and infestations
Epstein-Barr virus infection
|
11.1%
14/126 • Number of events 16
|
4.7%
6/128 • Number of events 7
|
|
Infections and infestations
Clostridial infection
|
4.0%
5/126 • Number of events 7
|
5.5%
7/128 • Number of events 8
|
|
Infections and infestations
Clostridium difficile colitis
|
8.7%
11/126 • Number of events 13
|
1.6%
2/128 • Number of events 3
|
|
Infections and infestations
Staphylococcal bacteraemia
|
7.1%
9/126 • Number of events 13
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
7.1%
9/126 • Number of events 9
|
2.3%
3/128 • Number of events 3
|
|
Infections and infestations
Epstein-Barr viraemia
|
6.3%
8/126 • Number of events 8
|
0.78%
1/128 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
27.0%
34/126 • Number of events 44
|
36.7%
47/128 • Number of events 48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.5%
22/126 • Number of events 42
|
9.4%
12/128 • Number of events 29
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
14/126 • Number of events 27
|
8.6%
11/128 • Number of events 21
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.5%
12/126 • Number of events 22
|
6.2%
8/128 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.5%
22/126 • Number of events 22
|
3.9%
5/128 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
11/126 • Number of events 12
|
0.78%
1/128 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
7/126 • Number of events 7
|
0.00%
0/128
|
|
Investigations
White blood cell count decreased
|
7.1%
9/126 • Number of events 15
|
3.9%
5/128 • Number of events 9
|
|
Investigations
Blood bilirubin increased
|
7.1%
9/126 • Number of events 14
|
1.6%
2/128 • Number of events 3
|
|
Investigations
Epstein-Barr virus test positive
|
5.6%
7/126 • Number of events 7
|
0.78%
1/128 • Number of events 3
|
|
Nervous system disorders
Headache
|
30.2%
38/126 • Number of events 44
|
14.8%
19/128 • Number of events 22
|
|
Nervous system disorders
Dizziness
|
6.3%
8/126 • Number of events 10
|
1.6%
2/128 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.6%
31/126 • Number of events 35
|
5.5%
7/128 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
7/126 • Number of events 7
|
0.78%
1/128 • Number of events 1
|
|
Vascular disorders
Hypotension
|
25.4%
32/126 • Number of events 36
|
4.7%
6/128 • Number of events 7
|
|
Vascular disorders
Hypertension
|
12.7%
16/126 • Number of events 17
|
4.7%
6/128 • Number of events 6
|
|
Vascular disorders
Flushing
|
7.1%
9/126 • Number of events 9
|
1.6%
2/128 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
18.3%
23/126 • Number of events 24
|
2.3%
3/128 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
15.1%
19/126 • Number of events 19
|
3.9%
5/128 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.9%
10/126 • Number of events 10
|
5.5%
7/128 • Number of events 9
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
7/126 • Number of events 7
|
4.7%
6/128 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.3%
8/126 • Number of events 8
|
0.78%
1/128 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
10.3%
13/126 • Number of events 13
|
4.7%
6/128 • Number of events 6
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.7%
16/126 • Number of events 30
|
3.1%
4/128 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place