Trial Outcomes & Findings for BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC) (NCT NCT01354431)
NCT ID: NCT01354431
Last Updated: 2022-05-12
Results Overview
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
From randomization to disease progression or death (up to approximately 2 years)
Results posted on
2022-05-12
Participant Flow
168 participants were randomized, 167 participants were treated.
Participant milestones
| Measure |
Nivolumab 0.3 mg/kg
Nivolumab 0.3 mg/kg IV Q3W
|
Nivolumab 2 mg/kg
Nivolumab 2 mg/kg IV Q3W
|
Nivolumab 10 mg/kg
Nivolumab 10 mg/kg IV Q3W
|
|---|---|---|---|
|
Pre-Treatment Period
STARTED
|
60
|
54
|
54
|
|
Pre-Treatment Period
COMPLETED
|
59
|
54
|
54
|
|
Pre-Treatment Period
NOT COMPLETED
|
1
|
0
|
0
|
|
Treatment Period
STARTED
|
59
|
54
|
54
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
59
|
54
|
54
|
Reasons for withdrawal
| Measure |
Nivolumab 0.3 mg/kg
Nivolumab 0.3 mg/kg IV Q3W
|
Nivolumab 2 mg/kg
Nivolumab 2 mg/kg IV Q3W
|
Nivolumab 10 mg/kg
Nivolumab 10 mg/kg IV Q3W
|
|---|---|---|---|
|
Pre-Treatment Period
Not reported
|
1
|
0
|
0
|
|
Treatment Period
Disease Progression
|
50
|
40
|
44
|
|
Treatment Period
Study Drug Toxicity
|
5
|
8
|
4
|
|
Treatment Period
Death
|
0
|
1
|
0
|
|
Treatment Period
AE unrelated to study drug
|
1
|
2
|
5
|
|
Treatment Period
Participant request to discontinue
|
2
|
2
|
1
|
|
Treatment Period
Participant withdrew consent
|
0
|
1
|
0
|
|
Treatment Period
Participant no longer meeting study criteria
|
1
|
0
|
0
|
Baseline Characteristics
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
Baseline characteristics by cohort
| Measure |
Nivolumab 0.3 mg/kg
n=60 Participants
Nivolumab 0.3 mg/kg IV Q3W
|
Nivolumab 2 mg/kg
n=54 Participants
Nivolumab 2 mg/kg IV Q3W
|
Nivolumab 10 mg/kg
n=54 Participants
Nivolumab 10 mg/kg IV Q3W
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From randomization to disease progression or death (up to approximately 2 years)Population: All randomized participants
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.
Outcome measures
| Measure |
Nivolumab 0.3 mg/kg
n=60 Participants
Nivolumab 0.3 mg/kg IV Q3W
|
Nivolumab 2 mg/kg
n=54 Participants
Nivolumab 2 mg/kg IV Q3W
|
Nivolumab 10 mg/kg
n=54 Participants
Nivolumab 10 mg/kg IV Q3W
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.63 Months
Interval 1.81 to 3.02
|
4.11 Months
Interval 2.86 to 5.39
|
4.17 Months
Interval 2.79 to 5.49
|
SECONDARY outcome
Timeframe: From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)Population: All randomized participants
BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 80% confidence interval is based on the Clopper and Pearson method
Outcome measures
| Measure |
Nivolumab 0.3 mg/kg
n=60 Participants
Nivolumab 0.3 mg/kg IV Q3W
|
Nivolumab 2 mg/kg
n=54 Participants
Nivolumab 2 mg/kg IV Q3W
|
Nivolumab 10 mg/kg
n=54 Participants
Nivolumab 10 mg/kg IV Q3W
|
|---|---|---|---|
|
Best Overall Response Rate (BORR)
|
20.0 Percent of participants
Interval 13.4 to 28.2
|
24.1 Percent of participants
Interval 16.6 to 33.1
|
20.4 Percent of participants
Interval 13.4 to 29.1
|
SECONDARY outcome
Timeframe: From randomization to to date of death (up to approximately 8 years)Population: All randomized participants
OS is defined as the time from date of randomization until date of death. If the participant did not die, overall survival will be censored on the last date the participant was known to be alive. Survival status is collected at each visit during treatment and every 3 months during follow-up. OS is based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Nivolumab 0.3 mg/kg
n=60 Participants
Nivolumab 0.3 mg/kg IV Q3W
|
Nivolumab 2 mg/kg
n=54 Participants
Nivolumab 2 mg/kg IV Q3W
|
Nivolumab 10 mg/kg
n=54 Participants
Nivolumab 10 mg/kg IV Q3W
|
|---|---|---|---|
|
Overall Survival (OS)
|
18.45 Months
Interval 16.23 to 23.98
|
25.46 Months
Interval 19.78 to 31.24
|
24.82 Months
Interval 15.31 to 25.95
|
SECONDARY outcome
Timeframe: From first dose to 30 days following last dose (up to approximately 6 years)Population: All treated participants
Number of participants experiencing different types of events, including Adverse Events (AEs), Drug-related AEs, AEs leading to discontinuation, Drug-related AEs leading to discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs. Events are classified based on the NCI Common Terminology Criteria (CTC) version 4.0
Outcome measures
| Measure |
Nivolumab 0.3 mg/kg
n=59 Participants
Nivolumab 0.3 mg/kg IV Q3W
|
Nivolumab 2 mg/kg
n=54 Participants
Nivolumab 2 mg/kg IV Q3W
|
Nivolumab 10 mg/kg
n=54 Participants
Nivolumab 10 mg/kg IV Q3W
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events
Any AEs
|
58 Participants
|
54 Participants
|
53 Participants
|
|
Number of Participants Experiencing Adverse Events
Drug-related AEs
|
44 Participants
|
36 Participants
|
41 Participants
|
|
Number of Participants Experiencing Adverse Events
AEs leading to discontinuation
|
6 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants Experiencing Adverse Events
Drug-related AEs leading to discontinuation
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Experiencing Adverse Events
SAEs
|
26 Participants
|
26 Participants
|
22 Participants
|
|
Number of Participants Experiencing Adverse Events
Drug-related SAEs
|
3 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
NIVOLUMAB 0.3 mg/kg
Serious events: 30 serious events
Other events: 55 other events
Deaths: 51 deaths
NIVOLUMAB 2 mg/kg
Serious events: 35 serious events
Other events: 54 other events
Deaths: 46 deaths
NIVOLUMAB 10 mg/kg
Serious events: 24 serious events
Other events: 52 other events
Deaths: 47 deaths
Serious adverse events
| Measure |
NIVOLUMAB 0.3 mg/kg
n=59 participants at risk
|
NIVOLUMAB 2 mg/kg
n=54 participants at risk
|
NIVOLUMAB 10 mg/kg
n=54 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Pericarditis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Endocrine disorders
Goitre
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Death
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Fatigue
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Gait disturbance
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
General physical health deterioration
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Influenza like illness
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Localised oedema
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Mucosal inflammation
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Oedema peripheral
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Pain
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Pyrexia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Hepatobiliary disorders
Cholangitis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Appendicitis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Biliary sepsis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Cellulitis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Klebsiella bacteraemia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Skin infection
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Influenza B virus test positive
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Liver function test increased
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Transaminases increased
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
10.2%
6/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Amnesia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Ataxia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Central nervous system lesion
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Neuropathy peripheral
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Seizure
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Spinal cord compression
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Product Issues
Device failure
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Renal and urinary disorders
Acute kidney injury
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Vascular disorders
Embolism
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Vascular disorders
Hypotension
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
Other adverse events
| Measure |
NIVOLUMAB 0.3 mg/kg
n=59 participants at risk
|
NIVOLUMAB 2 mg/kg
n=54 participants at risk
|
NIVOLUMAB 10 mg/kg
n=54 participants at risk
|
|---|---|---|---|
|
General disorders
Oedema
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Oedema peripheral
|
23.7%
14/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
18.5%
10/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
20.4%
11/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Blood and lymphatic system disorders
Anaemia
|
15.3%
9/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
14.8%
8/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
14.8%
8/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Palpitations
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Cardiac disorders
Tachycardia
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Endocrine disorders
Hypothyroidism
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Eye disorders
Vision blurred
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
8.5%
5/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Constipation
|
22.0%
13/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
35.2%
19/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
20.4%
11/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
15.3%
9/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
18.5%
10/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
29.6%
16/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
13.0%
7/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Nausea
|
27.1%
16/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
27.8%
15/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
22.2%
12/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Toothache
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Gastrointestinal disorders
Vomiting
|
20.3%
12/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
14.8%
8/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
18.5%
10/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Asthenia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Chest discomfort
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Chest pain
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Chills
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
13.0%
7/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Fatigue
|
42.4%
25/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
46.3%
25/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
53.7%
29/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Influenza like illness
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Mucosal inflammation
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Pain
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
General disorders
Pyrexia
|
10.2%
6/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
16.7%
9/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
11.1%
6/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Immune system disorders
Hypersensitivity
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
16.7%
9/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Bronchitis
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Rhinitis
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Sinusitis
|
11.9%
7/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
7/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
20.4%
11/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
14.8%
8/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Alanine aminotransferase increased
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Blood creatinine increased
|
11.9%
7/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Weight decreased
|
15.3%
9/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
13.0%
7/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
16.7%
9/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Investigations
Weight increased
|
11.9%
7/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.6%
8/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
27.8%
15/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
20.4%
11/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
11.1%
6/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
11.1%
6/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
13.0%
7/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
10/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
33.3%
18/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
29.6%
16/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.3%
12/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
31.5%
17/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
31.5%
17/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.2%
6/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
14.8%
8/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.3%
9/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
16.7%
9/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.5%
5/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
29.6%
16/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Dizziness
|
13.6%
8/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
13.0%
7/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Headache
|
11.9%
7/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
11.1%
6/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
16.7%
9/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Paraesthesia
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Nervous system disorders
Taste disorder
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Psychiatric disorders
Anxiety
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Psychiatric disorders
Depression
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Psychiatric disorders
Insomnia
|
10.2%
6/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
14.8%
8/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Renal and urinary disorders
Haematuria
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Renal and urinary disorders
Pollakiuria
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.9%
20/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
37.0%
20/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
20.4%
11/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.4%
15/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
20.4%
11/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
18.5%
10/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.5%
5/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
11.1%
6/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
3.4%
2/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
11.1%
6/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
18.5%
10/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
0.00%
0/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.8%
4/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
1.9%
1/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
11/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
13.0%
7/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
16.7%
9/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.6%
8/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
11.1%
6/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
22.2%
12/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
3.7%
2/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Vascular disorders
Flushing
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Vascular disorders
Hot flush
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Vascular disorders
Hypertension
|
5.1%
3/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
7.4%
4/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
|
Vascular disorders
Hypotension
|
0.00%
0/59 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
9.3%
5/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
5.6%
3/54 • All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).
All-cause mortality: all randomized participants SAEs and NSAEs: all treated participants
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER