Trial Outcomes & Findings for Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005) (NCT NCT04095858)
NCT ID: NCT04095858
Last Updated: 2023-02-08
Results Overview
Grade III-IV aGFS was defined as the time in days to the earlier of the first documented acute Grade III-IV GVHD or death by any cause in 180 days after hematopoietic stem cell transplantation (HCT). Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out or experience aGVHD or death were censored at the time of leukemia relapse or Day 180, whichever came first.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
Up to 180 days after HCT
Results posted on
2023-02-08
Participant Flow
Participants were recruited at 6 sites in the United States.
Eleven participants were screened but the decision was made to terminate the study after only 7 were randomized and treated in one of the study arms.
Participant milestones
| Measure |
Placebo Treatment
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Placebo Treatment
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Study terminated by Sponsor
|
2
|
4
|
Baseline Characteristics
Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 Participants
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 16.46 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 8.29 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 180 days after HCTPopulation: All randomized participants are included.
Grade III-IV aGFS was defined as the time in days to the earlier of the first documented acute Grade III-IV GVHD or death by any cause in 180 days after hematopoietic stem cell transplantation (HCT). Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out or experience aGVHD or death were censored at the time of leukemia relapse or Day 180, whichever came first.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 Participants
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
180 Day Grade III-IV Acute Graft-Versus-Host Disease (GVHD)-Free Survival (aGFS)
|
NA days
Interval 45.0 to
Median and upper limit of 95% CI not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA days
Median (95% CI) not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to 180 days after HCTPopulation: All randomized participants are included.
OS is defined as the time from HCT to death due to any cause. Participants who were alive at the end of the 180 days post HCT were censored at the last date they were known to be alive.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 Participants
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
Overall Survival (OS)
|
NA days
Interval 45.0 to
Median and upper limit of 95% CI not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA days
Median (95% CI) not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to 180 days after HCTPopulation: All randomized participants are included.
DFS is defined as the earlier of time to leukemia relapse, or death, whichever occurred first. Subjects that were alive and did not experience disease relapse at the end of the follow-up period (180 days after HCT) were censored at the last date of evaluation.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 Participants
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
Disease Free Survival (DFS)
|
NA days
Interval 45.0 to
Median and upper limit of 95% CI not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA days
Median (95% CI) not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to 180 days after HCTPopulation: All randomized participants are included.
Grade II-IV aGFS was defined as the time in days to the earlier of the first documented acute Grade II-IV GVHD or death by any cause in 180 days after HCT. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out or experience aGVHD or death were censored at the time of leukemia relapse or Day 180, whichever came first.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 Participants
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
180 Day Grade II-IV aGFS
|
45.0 days
Interval 29.0 to 56.0
|
NA days
Interval 28.0 to
Median and upper limit of 95% CI not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to 180 days after HCTPopulation: All randomized participants are included.
Grade III-IV aGVHD RFS was defined as the time in days to the earlier of the first documented acute Grade III-IV aGVHD, relapse, or death by any cause in 180 days after HCT. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out, experience Grade III-IV aGVHD, relapse, or death were censored at Day 180.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 Participants
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
180 Day Grade III-IV aGVHD-free and Relapse-free Survival (aGVHD RFS)
|
NA days
Interval 45.0 to
Median and upper limit of 95% CI not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA days
Interval 28.0 to
Median (95% CI) not reached at time of data cut-off due to insufficient number of participants with an event.
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
CD24Fc Treatment
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 participants at risk
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
Gastrointestinal disorders
Enterocolitis
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Nervous system disorders
Encephalopathy
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV \[0.03mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
CD24Fc Treatment
n=4 participants at risk
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV \[0.03 mg/kg/day\] or by mouth (PO) \[0.045 mg/kg/dose\] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m\^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m\^2/dose on days 3, 6, and 11 after HCT.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Enterocolitis
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Immune system disorders
Chronic graft versus host disease oral
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Infections and infestations
Escherichia bacteraemia
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Injury, poisoning and procedural complications
Vascular access site discharge
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Injury, poisoning and procedural complications
Vascular access site erythema
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Nervous system disorders
Encephalopathy
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Psychiatric disorders
Claustrophobia
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
33.3%
1/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Vascular disorders
Blue toe syndrome
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
25.0%
1/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
0.00%
0/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
50.0%
2/4 • Up to 180 days
All participants who received ≥1 dose of study therapy are included in assessment of adverse events (AEs) and serious AEs (SAEs). All-cause mortality was assessed in all randomized participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place