Trial Outcomes & Findings for Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation (NCT NCT03657160)
NCT ID: NCT03657160
Last Updated: 2023-06-06
Results Overview
Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
343 participants
Primary outcome timeframe
From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days
Results posted on
2023-06-06
Participant Flow
Participants took part in the study at 95 investigative sites in Canada, United States, Argentina, Brazil, Belgium, France, Germany, Italy, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, Austria, Greece, Hungary, Poland, Israel, Romania, Russia, Australia, Japan, Republic of Korea and Singapore from 6 February 2019 to 9 May 2022.
Participants undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT) were randomized into 1:1 ratio to receive Vedolizumab 300 mg or vedolizumab-matching placebo. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.
Participant milestones
| Measure |
Placebo
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
174
|
|
Overall Study
Safety Analysis Set
|
165
|
169
|
|
Overall Study
Full Analysis Set
|
165
|
168
|
|
Overall Study
COMPLETED
|
98
|
117
|
|
Overall Study
NOT COMPLETED
|
71
|
57
|
Reasons for withdrawal
| Measure |
Placebo
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
|
Overall Study
Protocol Deviation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
18
|
16
|
|
Overall Study
Site Termination
|
1
|
0
|
|
Overall Study
Unsatisfactory Therapeutic Response
|
5
|
3
|
|
Overall Study
Death
|
33
|
26
|
|
Overall Study
Death (COVID-19-Related)
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
5
|
5
|
|
Overall Study
Other (COVID-19-Related)
|
0
|
1
|
Baseline Characteristics
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
Baseline characteristics by cohort
| Measure |
Placebo
n=165 Participants
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=168 Participants
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 14.49 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 14.41 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 14.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 daysPopulation: FAS included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo HSCT. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.
Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Outcome measures
| Measure |
Placebo
n=165 Participants
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=168 Participants
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days
|
NA days
Interval 14.0 to 182.0
The median was not estimable due to censoring of participants.
|
NA days
Interval 2.0 to 182.0
The median was not estimable due to censoring of participants.
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180Population: FAS included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo HSCT. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.
Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.
Outcome measures
| Measure |
Placebo
n=165 Participants
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=168 Participants
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Intestinal aGvHD-Free and Relapse-Free Survival
|
NA days
Interval 14.0 to 182.0
The median was not estimable due to censoring of participants.
|
NA days
Interval 2.0 to 182.0
The median was not estimable due to censoring of participants.
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to first documented Grade C-D aGvHD or death, whichever occurs first up to Day +180Population: FAS included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo HSCT. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.
Grade C-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death, where an event is defined as Grade C-D aGvHD any organ involvement per International Bone Marrow Transplant Registry Database (IBMTR) Severity Index for aGvHD or death. It will be censored for participants who have not had the event or have had the event after pre-specified timing, eg, last contact or Day +180 after allo-HSCT whichever occurs first.
Outcome measures
| Measure |
Placebo
n=165 Participants
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=168 Participants
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Grade C-D aGvHD-Free Survival
|
NA days
Interval 12.0 to 182.0
The median was not estimable due to censoring of participants.
|
NA days
Interval 12.0 to 182.0
The median was not estimable due to censoring of participants.
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to first documented death without relapse, up to Day +180Population: FAS included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo HSCT. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.
Non-relapse mortality is the time from the date of first study drug administration (Day-1) to death without occurrence of a relapse. Data was censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Outcome measures
| Measure |
Placebo
n=165 Participants
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=168 Participants
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Nonrelapse Mortality (NRM)
|
NA days
Interval 14.0 to 182.0
The median was not estimable due to censoring of participants.
|
NA days
Interval 19.0 to 182.0
The median was not estimable due to censoring of participants.
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to first documented death up to Day +180Population: FAS included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo HSCT. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.
Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.
Outcome measures
| Measure |
Placebo
n=165 Participants
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=168 Participants
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Overall Survival (OS)
|
NA days
Interval 14.0 to 182.0
The median was not estimable due to censoring of participants.
|
NA days
Interval 19.0 to 182.0
The median was not estimable due to censoring of participants.
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to first documented grade B-D aGvHD or death, whichever occurs first up to Day +180Population: FAS included all participants who were randomized, received at least 1 dose of the treatment, and under-went allo HSCT. As pre-specified in the protocol, Day -1 corresponds to Day 1 of the ADaM data set, and similarly, Day 0 corresponds to Day 2. Therefore, the total duration becomes Day 182.
Grade B-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to aGvHD event or death, where an event is defined as death or grade B-D any organ involvement per IBMTR Severity Index for aGvHD.
Outcome measures
| Measure |
Placebo
n=165 Participants
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=168 Participants
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Grade B-D aGvHD-Free Survival
|
NA days
Interval 12.0 to 182.0
The median was not estimable due to censoring of participants.
|
NA days
Interval 12.0 to 182.0
The median was not estimable due to censoring of participants.
|
Adverse Events
Placebo
Serious events: 114 serious events
Other events: 164 other events
Deaths: 34 deaths
Vedolizumab 300 mg
Serious events: 120 serious events
Other events: 169 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Placebo
n=165 participants at risk
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=169 participants at risk
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.0%
5/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
3/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenias
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.0%
5/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
8/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
4.1%
7/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failures
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.6%
6/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
2.4%
4/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Hyperthermia
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
7.9%
13/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.7%
13/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.8%
3/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.0%
5/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Disease progression
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Polyserositis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Perforated ulcer
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Choleostasis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
9.7%
16/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.6%
6/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease
|
3.0%
5/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease in liver
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.0%
5/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease in skin
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.8%
3/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Engraftment syndrome
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease in liver
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease in eye
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease oral
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease in lung
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease oral
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic embolus
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease in lung
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Acinetobacter infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Anorectal cellulitis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Encephalitis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.6%
6/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis fungal
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Human herpesvirus 6 encephalitis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.8%
8/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.0%
5/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tracheobronchitis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
BK virus infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Human polyomavirus infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinovirus infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
5.5%
9/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
2.4%
4/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
2.4%
4/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
3.0%
5/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related sepsis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vascular device infection
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Prescribed overdose
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Engraft failure
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
2.4%
4/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.8%
3/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Delayed engraftment
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blast cell count increased
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase abnormal
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Liver function test abnormal
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma recurrent
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Minimal residual disease
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.8%
3/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Philadelphia positive acute lymphocytic leukaemia
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
5.5%
9/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia recurrent
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.8%
3/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.8%
3/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.0%
5/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified recurrent
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hemorrhage intracranial
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ataxia
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Altered state of consciousness
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Partial seizures
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.8%
3/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
2.4%
4/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
8/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.8%
3/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Prerenal failure
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
1.2%
2/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis obliterans syndrome
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
3/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
3/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.0%
5/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory failure
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Venoocclusive disease
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.00%
0/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
0.59%
1/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.61%
1/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.2%
2/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=165 participants at risk
Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
Vedolizumab 300 mg
n=169 participants at risk
Vedolizumab 300 mg, IV, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
61.8%
102/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
56.2%
95/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
54.5%
90/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
53.3%
90/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
50.3%
83/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
50.3%
85/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
37.6%
62/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
47.3%
80/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
43.6%
72/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
40.2%
68/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute Graft Versus Host Disease in Skin
|
39.4%
65/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
39.6%
67/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
32.7%
54/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
39.6%
67/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
35.2%
58/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
34.3%
58/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
31.5%
52/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
35.5%
60/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
32.7%
54/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
32.0%
54/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
32.7%
54/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
27.8%
47/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
55/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
24.3%
41/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
28.5%
47/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
25.4%
43/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
30.3%
50/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
22.5%
38/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
24.2%
40/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
26.6%
45/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet Count Decreased
|
28.5%
47/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
22.5%
38/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.8%
36/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
25.4%
43/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
31/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
25.4%
43/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.4%
32/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
23.7%
40/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.2%
35/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
20.1%
34/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
19.4%
32/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
20.7%
35/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
17.0%
28/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
21.9%
37/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
21.2%
35/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
17.2%
29/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
15.8%
26/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
21.3%
36/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
33/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
16.6%
28/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
21.2%
35/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
14.2%
24/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.1%
20/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
21.3%
36/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
15.2%
25/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
17.8%
30/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry Eye
|
12.7%
21/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
20.1%
34/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
17.0%
28/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
16.0%
27/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
25/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
15.4%
26/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Bilirubin Increased
|
16.4%
27/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
12.4%
21/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.3%
22/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
13.6%
23/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
13.9%
23/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
12.4%
21/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
12.7%
21/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
13.6%
23/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
19/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
14.2%
24/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
12.1%
20/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
12.4%
21/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
22/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
11.2%
19/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
9.7%
16/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
14.8%
25/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
12.7%
21/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
11.2%
19/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
22/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
9.5%
16/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.7%
16/165 • Number of events 17 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
13.0%
22/169 • Number of events 23 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.9%
13/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
13.6%
23/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.3%
17/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
10.7%
18/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.3%
17/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
10.1%
17/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.1%
20/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.7%
13/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.9%
18/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
8.9%
15/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.7%
16/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
10.1%
17/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
9.1%
15/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
10.7%
18/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.7%
16/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
9.5%
16/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.5%
14/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
10.7%
18/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
9.1%
15/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
9.5%
16/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
7.3%
12/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
11.2%
19/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.5%
14/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
8.3%
14/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil Count Decreased
|
9.1%
15/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.7%
13/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Investigations
White Blood Cell Count Decreased
|
10.9%
18/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.9%
10/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
7.3%
12/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
8.3%
14/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute Graft Versus Host Disease In Intestine
|
9.1%
15/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.9%
10/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
7.3%
12/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.7%
13/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.7%
11/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.7%
13/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic Graft Versus Host Disease Oral
|
6.1%
10/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
8.3%
14/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
9.1%
15/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic Graft Versus Host Disease In Skin
|
4.2%
7/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
9.5%
16/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Chronic Graft Versus Host Disease
|
7.3%
12/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.9%
10/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
9.1%
15/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
4.1%
7/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
7.9%
13/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.8%
8/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
8.3%
14/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
6.1%
10/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
6.5%
11/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
7.3%
12/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.5%
9/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.1%
12/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision Blurred
|
6.7%
11/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.9%
10/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
7.9%
13/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
4.1%
7/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
3.6%
6/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.7%
13/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy Peripheral
|
5.5%
9/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.9%
10/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral Pain
|
4.2%
7/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.1%
12/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.6%
6/165 • Number of events 7 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.1%
12/169 • Number of events 12 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
11/165 • Number of events 13 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
4.1%
7/169 • Number of events 9 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.5%
9/165 • Number of events 9 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • Number of events 9 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
3.6%
6/165 • Number of events 9 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
7.1%
12/169 • Number of events 13 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
5.5%
9/165 • Number of events 11 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
4.7%
8/169 • Number of events 9 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
5.5%
9/165 • Number of events 11 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
4.1%
7/169 • Number of events 8 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
4.2%
7/165 • Number of events 8 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • Number of events 9 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
6.7%
11/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
2.4%
4/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.5%
9/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
3.6%
6/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
10/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
2.4%
4/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional State
|
6.1%
10/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
1.8%
3/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
4/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
1.8%
3/165 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
5.3%
9/169 • From the first dose of study drug up to end of study (up to 39 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality was collected for all enrolled participants. SAEs and Non-SAEs were collected for safety population. Safety Population included all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER