Trial Outcomes & Findings for MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma (NCT NCT02724020)
NCT ID: NCT02724020
Last Updated: 2021-11-19
Results Overview
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
From first dose of study drug up to disease progression or death, assessed up to 43 months
Results posted on
2021-11-19
Participant Flow
Participants took part in the study at approximately 60-70 investigative sites in Czech Republic, France, Italy, Poland, Spain, United Kingdom, Canada and United States from 30 June 2016 to 13 October 2020.
Participants with a diagnosis of metastatic clear-cell renal cell carcinoma were randomized at a ratio of 1:1:1 to open label treatment period with single-agent MLN0128 and the combination of MLN0128 and MLN1117 compared with single-agent everolimus.
Participant milestones
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
|
Overall Study
Treated (Safety Analysis Set)
|
32
|
32
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
32
|
32
|
Reasons for withdrawal
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Overall Study
Death
|
16
|
18
|
19
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
|
Overall Study
Site Terminated by Sponsor
|
15
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
5
|
Baseline Characteristics
Number analyzed is the number of participants with data available for height at Baseline.
Baseline characteristics by cohort
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=32 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA (Median duration of treatment was 9.43 weeks up to end of study).
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 11.41 • n=32 Participants
|
61.6 years
STANDARD_DEVIATION 8.90 • n=32 Participants
|
63.3 years
STANDARD_DEVIATION 9.06 • n=32 Participants
|
63.2 years
STANDARD_DEVIATION 9.83 • n=96 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=32 Participants
|
10 Participants
n=32 Participants
|
7 Participants
n=32 Participants
|
23 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=32 Participants
|
22 Participants
n=32 Participants
|
25 Participants
n=32 Participants
|
73 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=32 Participants
|
30 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
85 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=32 Participants
|
9 Participants
n=96 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=96 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=32 Participants
|
29 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
83 Participants
n=96 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=32 Participants
|
3 Participants
n=32 Participants
|
4 Participants
n=32 Participants
|
11 Participants
n=96 Participants
|
|
Region of Enrollment
Czech Republic
|
1 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
4 Participants
n=96 Participants
|
|
Region of Enrollment
France
|
4 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
8 Participants
n=96 Participants
|
|
Region of Enrollment
Italy
|
11 Participants
n=32 Participants
|
9 Participants
n=32 Participants
|
4 Participants
n=32 Participants
|
24 Participants
n=96 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
5 Participants
n=96 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=32 Participants
|
6 Participants
n=32 Participants
|
7 Participants
n=32 Participants
|
19 Participants
n=96 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=32 Participants
|
4 Participants
n=32 Participants
|
9 Participants
n=32 Participants
|
17 Participants
n=96 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
5 Participants
n=96 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=32 Participants
|
7 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
14 Participants
n=96 Participants
|
|
Height
|
170.23 cm
STANDARD_DEVIATION 8.489 • n=31 Participants • Number analyzed is the number of participants with data available for height at Baseline.
|
171.16 cm
STANDARD_DEVIATION 10.626 • n=32 Participants • Number analyzed is the number of participants with data available for height at Baseline.
|
172.01 cm
STANDARD_DEVIATION 8.349 • n=31 Participants • Number analyzed is the number of participants with data available for height at Baseline.
|
171.13 cm
STANDARD_DEVIATION 9.159 • n=94 Participants • Number analyzed is the number of participants with data available for height at Baseline.
|
|
Weight
|
75.69 kg
STANDARD_DEVIATION 12.449 • n=31 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
78.12 kg
STANDARD_DEVIATION 15.473 • n=32 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
80.40 kg
STANDARD_DEVIATION 17.896 • n=32 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
78.10 kg
STANDARD_DEVIATION 15.419 • n=95 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
PRIMARY outcome
Timeframe: From first dose of study drug up to disease progression or death, assessed up to 43 monthsPopulation: Full Analysis Set included all randomized participants.
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=32 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
3.8 months
Interval 2.0 to 5.4
|
3.6 months
Interval 1.9 to 5.7
|
3.1 months
Interval 1.9 to 5.4
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (approximately up to 31 months)Population: Safety Analysis Set included participants who receive at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAE was defined as the event that occur after administration of the first dose of study drug and through 30 days after the last dose of study drug.
Outcome measures
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=31 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
32 Participants
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after the last dose of study drug (up to 51 months)Population: Full Analysis Set included all randomized participants.
Overall survival in months was defined as the time from the date of randomization to the date of death.
Outcome measures
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=32 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Overall Survival (OS)
|
22.4 months
Interval 8.2 to
The upper limit of confidence interval (CI) was not estimable due to fewer number of participants with event.
|
16.2 months
Interval 9.0 to 19.9
|
18.1 months
Interval 6.2 to 23.4
|
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death (up to 51 months)Population: Full Analysis Set included all randomized participants.
TTP in months is defined as the time from the date of randomization to the date of first documentation of progression. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=32 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Time-to-progression (TTP)
|
3.8 months
Interval 2.0 to 15.6
|
3.5 months
Interval 1.9 to 7.4
|
3.7 months
Interval 1.9 to 10.5
|
SECONDARY outcome
Timeframe: From first dose of study drug to disease progression or death (up to 51 months)Population: Response Evaluable Analysis Set included participants who receive at least 1 dose of study drug, have measurable disease at Baseline and have 1 postbaseline disease assessment.
ORR was defined as the percentage of participants among response evaluable analysis set who achieve a best overall response of complete response (CR) or partial response (PR) based on investigators assessment of response following RECIST 1.1. CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Outcome measures
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=31 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
15.6 percentage of participants
|
0 percentage of participants
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death (up to 51 months)Population: Response Evaluable Analysis Set included participants who receive at least 1 dose of study drug, have measurable disease at Baseline and have 1 postbaseline disease assessment.
CBR is defined as the percentage of participants who achieve a best response of CR, PR or stable disease (SD) of any duration. CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=31 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
62.5 percentage of participants
|
50.0 percentage of participants
|
54.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Response Evaluable Analysis Set included participants who receive at least 1 dose of study drug, have measurable disease at Baseline and have 1 postbaseline disease assessment.
CBR with SD duration of at least 4 months (CBR-16) was defined as the percentage of participants who achieve CR or PR of any duration or have SD with duration of at least 16 weeks. CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 Participants
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 Participants
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=31 Participants
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
CBR With SD Duration of at Least 16 Weeks
|
40.6 percentage of participants
|
25.0 percentage of participants
|
29.0 percentage of participants
|
Adverse Events
Arm A: Single-agent Everolimus 10 mg QD
Serious events: 19 serious events
Other events: 32 other events
Deaths: 16 deaths
Arm B: Single-agent MLN0128 30 mg QW
Serious events: 13 serious events
Other events: 29 other events
Deaths: 18 deaths
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
Serious events: 15 serious events
Other events: 31 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 participants at risk
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 participants at risk
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=31 participants at risk
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Abscess jaw
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Pyrexia
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Vascular disorders
Infarction
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
Other adverse events
| Measure |
Arm A: Single-agent Everolimus 10 mg QD
n=32 participants at risk
Everolimus 10 mg capsules, orally, once daily in a 28-day treatment cycle until disease progression, consent withdrawal, death, or transfer to the Post-trial Access (PTA) program (Median duration of treatment was 15.43 weeks up to end of study).
|
Arm B: Single-agent MLN0128 30 mg QW
n=32 participants at risk
MLN0128 30 mg capsules, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.64 weeks up to end of study).
|
Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD
n=31 participants at risk
MLN0128 4 mg and MLN1117 200 mg capsules, orally, both once daily for 3 days per week (QD X 3) on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day treatment cycle until disease progression, unacceptable toxicity, consent withdrawal, death, or transfer to the PTA program (Median duration of treatment was 9.43 weeks up to end of study).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
21.9%
7/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
68.8%
22/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
54.8%
17/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
21.9%
7/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
43.8%
14/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
41.9%
13/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.6%
13/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
25.0%
8/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
35.5%
11/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
28.1%
9/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
37.5%
12/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
16.1%
5/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
37.5%
12/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
18.8%
6/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.6%
5/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
15.6%
5/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
19.4%
6/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
16.1%
5/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Asthenia
|
59.4%
19/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
37.5%
12/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
29.0%
9/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Fatigue
|
31.2%
10/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
18.8%
6/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
38.7%
12/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Pyrexia
|
31.2%
10/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
16.1%
5/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Chest pain
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Influenza like illness
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Chills
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Pain
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
46.9%
15/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
31.2%
10/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
35.5%
11/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
25.8%
8/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
15.6%
5/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
37.5%
12/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
19.4%
6/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
16.1%
5/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
18.8%
6/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.2%
10/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
31.2%
10/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
16.1%
5/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.4%
11/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
31.2%
10/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Weight decreased
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
28.1%
9/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
16.1%
5/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.9%
4/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.9%
4/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Amylase increased
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Investigations
Lipase increased
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Headache
|
18.8%
6/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.9%
4/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.6%
5/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
21.9%
7/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.8%
6/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.7%
3/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Influenza
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
18.8%
6/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.9%
4/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
4/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
18.8%
6/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
12.9%
4/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
9.4%
3/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.2%
1/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
2/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
3.1%
1/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
0.00%
0/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
15.6%
5/32 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
6.5%
2/31 • All-cause mortality: From first dose of study drug through end of the study (up to 51 months); Serious and other (non-serious) AEs: From first dose of study drug through 30 days after the last dose of study drug (up to 31 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All-cause mortality: Data is reported for Full Analysis Set, defined as all randomized participants (N= 32, 32, 32). Adverse Events: Data for is reported for Safety Analysis Set, including participants who received \>=1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER