Trial Outcomes & Findings for Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis (NCT NCT01659658)
NCT ID: NCT01659658
Last Updated: 2025-09-02
Results Overview
Overall hematologic response was defined as the percentage of participants with complete response (CR), very good partial response (VGPR) and partial response (PR) based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as assessed by an adjudication committee. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of free light chain (FLC) ratio. VGPR: differential free light chain (difference between involved and uninvolved FLC levels; dFLC) \< 40 mg/L. PR: ≥50% reduction in dFLC. Percentages were rounded off to the nearest decimal.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
177 participants
Primary outcome timeframe
From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
Results posted on
2025-09-02
Participant Flow
Participants took part in the study at 66 investigative sites from 12 December 2012 to 11 July 2022. The study was prematurely terminated based on the Sponsor's decision following the first interim analysis.
Participants with a diagnosis of relapsed or refractory (R/R) systemic light chain amyloidosis (AL) were enrolled in the study to receive ixazomib capsules or physician's choice of therapy, which included dexamethasone tablets alone or in combination with either melphalan, cyclophosphamide, thalidomide or lenalidomide.
Participant milestones
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
90
|
26
|
10
|
2
|
49
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
90
|
26
|
10
|
2
|
49
|
Reasons for withdrawal
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Patient
|
18
|
4
|
2
|
0
|
11
|
|
Overall Study
Study Terminated by Sponsor
|
9
|
7
|
0
|
1
|
4
|
|
Overall Study
Reason not Specified
|
61
|
15
|
8
|
1
|
34
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Number analyzed is the number of participants with data available for height.
Baseline characteristics by cohort
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=26 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
n=10 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
n=2 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
n=49 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 9.83 • n=90 Participants
|
64.8 years
STANDARD_DEVIATION 8.73 • n=26 Participants
|
60.0 years
STANDARD_DEVIATION 14.97 • n=10 Participants
|
65.0 years
STANDARD_DEVIATION 2.83 • n=2 Participants
|
64.9 years
STANDARD_DEVIATION 8.68 • n=49 Participants
|
63.9 years
STANDARD_DEVIATION 9.65 • n=177 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=90 Participants
|
11 Participants
n=26 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
22 Participants
n=49 Participants
|
74 Participants
n=177 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=90 Participants
|
15 Participants
n=26 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
27 Participants
n=49 Participants
|
103 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=90 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=90 Participants
|
25 Participants
n=26 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
40 Participants
n=49 Participants
|
161 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
7 Participants
n=49 Participants
|
13 Participants
n=177 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=90 Participants
|
9 Participants
n=26 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=49 Participants
|
32 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=177 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=90 Participants
|
17 Participants
n=26 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
48 Participants
n=49 Participants
|
141 Participants
n=177 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
3 Participants
n=177 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=49 Participants
|
9 Participants
n=177 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=90 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
13 Participants
n=49 Participants
|
42 Participants
n=177 Participants
|
|
Region of Enrollment
Czechia
|
2 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=177 Participants
|
|
Region of Enrollment
Denmark
|
0 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=177 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=90 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=49 Participants
|
5 Participants
n=177 Participants
|
|
Region of Enrollment
Germany
|
8 Participants
n=90 Participants
|
5 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=49 Participants
|
16 Participants
n=177 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=90 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=49 Participants
|
17 Participants
n=177 Participants
|
|
Region of Enrollment
Greece
|
6 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
7 Participants
n=49 Participants
|
15 Participants
n=177 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=49 Participants
|
7 Participants
n=177 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=90 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
4 Participants
n=177 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=90 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=49 Participants
|
5 Participants
n=177 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=177 Participants
|
|
Region of Enrollment
Australia
|
8 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=49 Participants
|
14 Participants
n=177 Participants
|
|
Region of Enrollment
Brazil
|
0 Participants
n=90 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=177 Participants
|
|
Region of Enrollment
China
|
4 Participants
n=90 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
6 Participants
n=177 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=90 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=49 Participants
|
8 Participants
n=177 Participants
|
|
Region of Enrollment
Japan
|
2 Participants
n=90 Participants
|
5 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=49 Participants
|
7 Participants
n=177 Participants
|
|
Region of Enrollment
Korea, Republic of
|
7 Participants
n=90 Participants
|
2 Participants
n=26 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=49 Participants
|
14 Participants
n=177 Participants
|
|
Height
|
170.40 centimeters (cm)
STANDARD_DEVIATION 10.507 • n=90 Participants • Number analyzed is the number of participants with data available for height.
|
167.07 centimeters (cm)
STANDARD_DEVIATION 8.662 • n=26 Participants • Number analyzed is the number of participants with data available for height.
|
170.65 centimeters (cm)
STANDARD_DEVIATION 13.274 • n=10 Participants • Number analyzed is the number of participants with data available for height.
|
160.50 centimeters (cm)
STANDARD_DEVIATION 13.435 • n=2 Participants • Number analyzed is the number of participants with data available for height.
|
169.17 centimeters (cm)
STANDARD_DEVIATION 10.532 • n=48 Participants • Number analyzed is the number of participants with data available for height.
|
169.48 centimeters (cm)
STANDARD_DEVIATION 10.444 • n=176 Participants • Number analyzed is the number of participants with data available for height.
|
|
Weight
|
77.33 kilograms (kg)
STANDARD_DEVIATION 16.740 • n=90 Participants
|
70.95 kilograms (kg)
STANDARD_DEVIATION 12.476 • n=26 Participants
|
70.20 kilograms (kg)
STANDARD_DEVIATION 21.815 • n=10 Participants
|
50.10 kilograms (kg)
STANDARD_DEVIATION 15.415 • n=2 Participants
|
75.35 kilograms (kg)
STANDARD_DEVIATION 17.144 • n=49 Participants
|
75.13 kilograms (kg)
STANDARD_DEVIATION 16.830 • n=177 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
Overall hematologic response was defined as the percentage of participants with complete response (CR), very good partial response (VGPR) and partial response (PR) based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as assessed by an adjudication committee. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of free light chain (FLC) ratio. VGPR: differential free light chain (difference between involved and uninvolved FLC levels; dFLC) \< 40 mg/L. PR: ≥50% reduction in dFLC. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=85 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=24 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
n=10 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
n=2 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
n=47 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Overall Hematologic Response
|
53 percentage of participants
Interval 41.8 to 63.9
|
58 percentage of participants
Interval 36.6 to 77.9
|
30 percentage of participants
Interval 6.7 to 65.2
|
50 percentage of participants
Interval 1.3 to 98.7
|
51 percentage of participants
Interval 36.1 to 65.9
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
Cardiac (Heart) deterioration was defined as the need for hospitalization for heart failure. Kidney deterioration was defined as progression to end-stage renal disease (ESRD) with the need for maintenance dialysis or renal transplantation. Vital organ deterioration was evaluated by an adjudication committee. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=85 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=83 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
2-Year Vital Organ (Heart or Kidney) Deterioration and Mortality Rate
|
47 percentage of participants
Interval 36.1 to 58.2
|
54 percentage of participants
Interval 41.7 to 64.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized.
Complete hematologic response was defined as the percentage of participants with CR based on central laboratory results and the 2010 ISA Consensus Criteria as assessed by the investigator. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of FLC ratio. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=87 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Hematologic Response
|
30 percentage of participants
Interval 20.8 to 40.6
|
17 percentage of participants
Interval 10.0 to 26.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized.
Overall survival was defined as the time from the date of randomization to the date of death. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=87 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Overall Survival
|
69.55 months
Interval 0.8 to 95.5
|
43.17 months
Interval 0.0 to 82.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized.
PFS was defined as the time from the date of randomization to the date of first documentation of hematologic disease progression, or organ (cardiac or renal) progression, or death due to any cause, whichever occurred first according to central laboratory results and ISA criteria as evaluated by the investigator. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=87 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
11.86 months
Interval 0.8 to 72.0
|
7.62 months
Interval 0.0 to 71.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
Hematologic disease PFS was defined as the time from the date of randomization to the date of first documentation of hematologic PD according to central laboratory results and ISA criteria as evaluated by an adjudication committee, or death due to any cause, whichever occurred first. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=85 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=83 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Hematologic Disease Progression Free Survival
|
29.50 months
Interval 0.1 to 54.5
|
27.73 months
Interval 0.1 to 43.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to time of vital organ deterioration or death (up to 115 months)Population: ITT Population included all participants who were randomized.
Time to vital organ deterioration or death was assessed by the investigator and defined as the time from randomization to vital organ (heart or kidney) deterioration or death, whichever occurs first. Cardiac deterioration is defined as the need for hospitalization for heart failure. Kidney deterioration is defined as progression to ESRD with the need for maintenance dialysis or renal transplantation. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=87 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Time to Vital Organ (Heart or Kidney) Deterioration and Mortality Rate
|
38.67 months
Interval 0.0 to 70.5
|
26.09 months
Interval 0.0 to 71.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
Vital organ (heart and kidney) response rate was defined as the percentage of participants who achieved vital organ response according to central laboratory results and ISA criteria as evaluated by an adjudication committee. A vital organ response was defined as response of 1 or 2 of the involved vital organs with no change from Baseline in the rest of involved vital organs. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=85 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=83 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Best Vital Organ (Cardiac and/or Kidney) Response
|
19 percentage of participants
Interval 11.2 to 28.8
|
12 percentage of participants
Interval 5.9 to 21.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized.
Vital organ PFS is defined as the time from the date of randomization to the date of first documentation of progression of vital organ (heart or kidney) according to central laboratory results and ISA criteria as evaluated by an adjudication committee, or death due to any cause, whichever occurs first. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=87 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Vital Organ Progression Free Survival
|
15.77 months
Interval 0.0 to 72.0
|
11.01 months
Interval 0.0 to 71.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From time of first documented response to disease progression (up to 115 months)Population: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of hematologic responders.
Duration of hematologic response (DOR) was defined as the time from the date of first documentation of a hematologic response to the date of first documented hematologic disease progression as determined by the investigator. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=49 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=45 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Duration of Hematologic Response
|
NA months
Interval 1.8 to 71.1
Median was not estimable due to excess amount of censoring among the participants for the analysis.
|
21.19 months
Interval 0.0 to 69.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)Population: Safety Population included all participants who received at least 1 dose of any treatment drug.
A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or medically important event.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=26 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
n=10 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
n=1 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
n=47 Participants
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
44 Participants
|
11 Participants
|
2 Participants
|
0 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized.
TTF was defined as the time from randomization to the date of first documented treatment failure. Treatment failure was defined as: 1) death due to any cause; 2) hematologic progression or major organ progression according to central laboratory results and ISA criteria as evaluated by the investigator; 3) clinically morbid organ disease requiring additional therapy; or 4) withdrawn for any reason. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=87 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Time To Treatment Failure (TTF)
|
10.32 months
Interval 7.52 to 14.82
|
5.32 months
Interval 4.14 to 7.82
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until subsequent anticancer treatment (up to 115 months)Population: ITT Population included all participants who were randomized.
Time to subsequent anticancer therapy was defined as the time from randomization to the first date of subsequent anticancer therapy. Participants without subsequent anticancer therapy were censored at the date of death or last known to be alive. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=87 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Time To Subsequent Anticancer Treatment
|
26.48 months
Interval 0.8 to 95.5
|
12.45 months
Interval 0.0 to 72.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 28 of the PFS Follow-upPopulation: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
SF-36 Version 2 is a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100, where higher scores are associated with less disability and better quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=1 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in 36-item Short Form General Health Survey (SF-36) Mental Component Summary Score at Week 28 of the PFS Follow-up
|
—
|
2.0 score on a scale
Standard Deviation NA
Standard deviation (SD) was not estimable for 1 participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 28 of the PFS Follow-upPopulation: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
SF-36 Version 2 is a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100, where higher scores are associated with less disability and better quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=1 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Physical Component Summary Score at Week 28 of the PFS Follow-up
|
—
|
10.3 score on a scale
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 28 of the PFS Follow-upPopulation: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
The FACT/GOG-Ntx is a participant completed questionnaire that comprises 11 individual items evaluating symptoms of neurotoxicity on a 5-point scale where: 0=not at all (best) to 4=very much for a total possible score of 0 to 44. Symptom scores are inverted so that higher scores of FACT/GOG-Ntx indicate higher quality of life or functioning. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=1 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Score at Week 28 of the PFS Follow-up
|
—
|
0.0 score on a scale
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 28 of the PFS Follow-upPopulation: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
The amyloidosis symptom scale questionnaire is a participant completed questionnaire that evaluates symptom severity of 3 symptoms: Swelling, Shortness of Breath and Dizziness, each rated on an 11-point scale where: 0=no symptoms to 10=very severe symptoms. Higher scores indicate worsening of symptoms. Total Score is the sum of all responses from the amyloidosis symptom scale ranging from 0 to 30. Higher scores represent higher levels of symptomatology or problems and a negative change from baseline indicates improvement. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=1 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Amyloidosis Symptom Scale Total Score at Week 28 of the PFS Follow-up
|
—
|
-16.0 score on a scale
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 28 of the OS follow-upPopulation: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
The European Quality of Life (EuroQOL) 5-Dimensional (EQ-5D) is a patient completed questionnaire consisting of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 3 possible choices: no problems to extreme problems. Higher scores=worsening of the quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=1 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Mobility: No Problems in Walking About
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Mobility: Some Problem in Walking About
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Mobility: Confined to Bed
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Self-Care: No Problems With Self- Care
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Self-Care: Some Problems Washing or Dressing
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Self-Care: Unable to Wash or Dress
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Usual Activities: No Problems With Performing Usual Activities
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Usual Activities: Some Problem With Performing Usual Activities
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Usual Activities: Unable to Performing Usual Activities
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Pain/Discomfort: No Pain or Discomfort
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Pain/Discomfort: Moderate Pain or Discomfort
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Pain/Discomfort: Extreme Pain or Discomfort
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Anxiety/Depression: Not Anxious or Depressed
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Anxiety/Depression: Moderately Anxious or Depressed
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
Anxiety/Depression: Extremely Anxious or Depressed
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 28 of the OS follow-upPopulation: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
The EQ visual analogue scale (VAS) records the participant's self-rated health on a 20 centimeter vertical VAS that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the value collected at the time closest to, but prior to, the start of study drug administration. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=1 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analogue Scale Score
|
—
|
23.0 score on a scale
Standard Deviation NA
SD was not estimable for 1 participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: 1, 4 hours postdose, Day 14: 144 hours postdose; Cycle 2, Day 1: predose, Day 14: 144 hours postdose; Cycles 3 to 10, Day 1: predose (cycle length=28 days)Population: Pharmacokinetic (PK) Analysis Population included participants with at least one PK sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
As prespecified in the protocol, data for this outcome measure was planned to be collected for ixazomib arm group only.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=78 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Plasma Concentration of Ixazomib
Cycle 1 Day 1: 1 Hour Post-dose
|
16.518 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 97.0462
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 1 Day 14: 4 Hours Post-dose
|
10.652 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 121.7231
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 1 Day 14: 144 Hours Post-dose
|
3.875 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 100.3055
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 2 Day 1: Pre-dose
|
2.000 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.4061
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 2 Day 14: 144 Hours Post-dose
|
4.726 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 115.5653
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 3 Day 1: Pre-dose
|
2.187 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.1378
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 4 Day 1 Pre-dose
|
2.276 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.3690
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 5 Day 1 Pre-dose
|
2.264 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54.8881
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 6 Day 1: Pre-dose
|
2.235 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60.4723
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 7 Day 1: Pre-dose
|
2.299 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.7147
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 8 Day 1: Pre-dose
|
2.038 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.6811
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 9 Day 1: Pre-dose
|
2.143 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.0715
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Ixazomib
Cycle 10 Day 1: Pre-dose
|
2.232 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 57.4067
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)Population: ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
A hospitalization was defined as at least one overnight stay in an intensive care unit and/or non-intensive care unit. If a single hospitalization included both an intensive care unit stay and a non-intensive care unit stay, the hospitalization was counted only once (as an intensive care unit stay). The mean number of hospitalizations is reported in this outcome measure. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure.
Outcome measures
| Measure |
Arm A: Ixazomib + Dexamethasone
n=85 Participants
Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=83 Participants
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Number of Hospitalizations
|
1.8 hospitalizations
Standard Deviation 1.34
|
1.4 hospitalizations
Standard Deviation 0.80
|
—
|
—
|
—
|
Adverse Events
Arm A: Ixazomib + Dexamethasone
Serious events: 44 serious events
Other events: 86 other events
Deaths: 40 deaths
Arm B: Dexamethasone + Melphalan
Serious events: 11 serious events
Other events: 24 other events
Deaths: 14 deaths
Arm B: Dexamethasone + Cyclophosphamide
Serious events: 2 serious events
Other events: 9 other events
Deaths: 4 deaths
Arm B: Dexamethasone + Thalidomide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B: Dexamethasone + Lenalidomide
Serious events: 17 serious events
Other events: 46 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 participants at risk
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=26 participants at risk
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
n=10 participants at risk
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
n=1 participants at risk
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
n=47 participants at risk
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Asthenia
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Atrial flutter
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Investigations
Body temperature increased
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Bronchitis
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
COVID-19
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Cardiac arrest
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Cardiac failure
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Eye disorders
Cataract
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Cellulitis
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Chest pain
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Clostridium difficile infection
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Coronary artery dissection
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Fatigue
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Herpes zoster cutaneous disseminated
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Vascular disorders
Hypotension
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Influenza
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Oedema peripheral
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Peritonitis
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Pneumonia
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
15.4%
4/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Pneumonia chlamydial
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Pneumonia fungal
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Pyrexia
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Sepsis
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Spinal cord infarction
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Subileus
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Sudden cardiac death
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Syncope
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
Other adverse events
| Measure |
Arm A: Ixazomib + Dexamethasone
n=90 participants at risk
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
|
Arm B: Dexamethasone + Melphalan
n=26 participants at risk
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Cyclophosphamide
n=10 participants at risk
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Thalidomide
n=1 participants at risk
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
|
Arm B: Dexamethasone + Lenalidomide
n=47 participants at risk
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
10/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
9/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
15.4%
4/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
19.1%
9/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Psychiatric disorders
Anxiety
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
11/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Asthenia
|
8.9%
8/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
12.8%
6/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
15/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.6%
5/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Investigations
Blood creatinine increased
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
12.8%
6/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Bronchitis
|
8.9%
8/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Eye disorders
Cataract
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Chills
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
18/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
40.0%
4/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
27.7%
13/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.4%
13/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.2%
11/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Psychiatric disorders
Depression
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.6%
32/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
15.4%
4/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
46.8%
22/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Dizziness
|
15.6%
14/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
14.9%
7/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Dizziness postural
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Dysaesthesia
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.1%
19/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
25.5%
12/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
10/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Fatigue
|
44.4%
40/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
26.9%
7/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
30.0%
3/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
51.1%
24/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Headache
|
11.1%
10/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Herpes zoster
|
8.9%
8/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Vascular disorders
Hypertension
|
12.2%
11/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Vascular disorders
Hypotension
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Influenza
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Influenza like illness
|
8.9%
8/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Psychiatric disorders
Insomnia
|
35.6%
32/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
17.0%
8/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Eye disorders
Lacrimation increased
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Malaise
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Psychiatric disorders
Mood altered
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Psychiatric disorders
Mood swings
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
9/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
14.9%
7/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.3%
12/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Eye disorders
Myopia
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
8/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
40.0%
4/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Nausea
|
25.6%
23/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
15.4%
4/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
30.0%
3/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.6%
5/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Non-cardiac chest pain
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Oedema peripheral
|
45.6%
41/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
26.9%
7/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
30.0%
3/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
36.2%
17/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Vascular disorders
Orthostatic hypotension
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
10/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Palpitations
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Paraesthesia
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
20/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
21.3%
10/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Peripheral swelling
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
4.3%
2/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Investigations
Platelet count decreased
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Pneumonia
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
General disorders
Pyrexia
|
7.8%
7/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
14.9%
7/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
12/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Respiratory tract infection
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Cardiac disorders
Sinus tachycardia
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Syncope
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Nervous system disorders
Taste disorder
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
7.7%
2/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
100.0%
1/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Tooth abscess
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
24.4%
22/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
21.3%
10/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
3/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
10.0%
1/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Ear and labyrinth disorders
Vertigo
|
4.4%
4/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.2%
2/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
6.4%
3/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Eye disorders
Vision blurred
|
5.6%
5/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.4%
13/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
11.5%
3/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
20.0%
2/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
12.8%
6/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Investigations
Weight decreased
|
1.1%
1/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
8.5%
4/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
|
Investigations
Weight increased
|
6.7%
6/90 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
3.8%
1/26 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/10 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
0.00%
0/1 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment drug.
|
2.1%
1/47 • From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
All-cause mortality: ITT Population included all participants who were randomized. Serious and other adverse events: Safety Population included all participants who received at least 1 dose of any treatment 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