Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (NCT NCT03434379)
NCT ID: NCT03434379
Last Updated: 2023-10-23
Results Overview
OS was defined as the time from randomization to death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
558 participants
Primary outcome timeframe
From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
Results posted on
2023-10-23
Participant Flow
Participants were enrolled at 117 sites in 17 countries: Australia, Canada, China, Czech Republic, Germany, Spain, France, United Kingdom, Hong Kong, Italy, Japan, Republic of Korea, Poland, Russian Federation, Singapore, Taiwan, United States.
The total study population included 558 participants. The Global population included 501 participants. An additional 57 participants enrolled during the China Extension. The total China population included 137 Chinese participants from the Global population plus 57 participants from the China extension. 137 participants were part of the Global as well as China populations. Separate analyses were performed for the Global population and the China population in the study.
Participant milestones
| Measure |
Sorafenib - Global
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Sorafenib - China
Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - China
Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|---|---|
|
Global Period
STARTED
|
165
|
336
|
0
|
0
|
|
Global Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Global Period
NOT COMPLETED
|
165
|
336
|
0
|
0
|
|
China Extension Period
STARTED
|
0
|
0
|
61
|
133
|
|
China Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
China Extension Period
NOT COMPLETED
|
0
|
0
|
61
|
133
|
Reasons for withdrawal
| Measure |
Sorafenib - Global
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Sorafenib - China
Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - China
Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|---|---|
|
Global Period
Lost to Follow-up
|
3
|
6
|
0
|
0
|
|
Global Period
Death
|
115
|
228
|
0
|
0
|
|
Global Period
Withdrawal by Subject
|
20
|
21
|
0
|
0
|
|
Global Period
Reason Unspecified
|
0
|
1
|
0
|
0
|
|
Global Period
Study Ended by Sponsor
|
26
|
80
|
0
|
0
|
|
Global Period
Physician Decision
|
1
|
0
|
0
|
0
|
|
China Extension Period
Lost to Follow-up
|
0
|
0
|
2
|
3
|
|
China Extension Period
Death
|
0
|
0
|
46
|
88
|
|
China Extension Period
Withdrawal by Subject
|
0
|
0
|
8
|
6
|
|
China Extension Period
Study Ended by Sponsor
|
0
|
0
|
5
|
36
|
Baseline Characteristics
The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
Baseline characteristics by cohort
| Measure |
Sorafenib - All
n=183 Participants
All participants either in the Global or China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - All
n=375 Participants
All participants either in the Global or China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Total
n=558 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
China · Unknown or Not Reported
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Age, Continuous
Global
|
64.4 years
STANDARD_DEVIATION 10.9 • n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
62.9 years
STANDARD_DEVIATION 11.9 • n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
63.4 years
STANDARD_DEVIATION 11.6 • n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Age, Continuous
China
|
57.5 years
STANDARD_DEVIATION 12.7 • n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
55.3 years
STANDARD_DEVIATION 12.0 • n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
56.0 years
STANDARD_DEVIATION 12.3 • n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Sex: Female, Male
Global · Female
|
28 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
59 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
87 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Sex: Female, Male
Global · Male
|
137 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
277 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
414 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Sex: Female, Male
China · Female
|
12 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
17 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
29 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Sex: Female, Male
China · Male
|
49 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
116 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
165 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Ethnicity (NIH/OMB)
Global · Hispanic or Latino
|
4 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
9 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
13 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Ethnicity (NIH/OMB)
Global · Not Hispanic or Latino
|
149 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
306 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
455 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Ethnicity (NIH/OMB)
Global · Unknown or Not Reported
|
12 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
21 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
33 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Ethnicity (NIH/OMB)
China · Hispanic or Latino
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Ethnicity (NIH/OMB)
China · Not Hispanic or Latino
|
61 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
133 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
194 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Ethnicity (NIH/OMB)
China · Unknown or Not Reported
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
Global · American Indian or Alaska Native
|
1 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
1 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
Global · Asian
|
96 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
188 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
284 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
Global · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
Global · Black or African American
|
4 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
6 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
10 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
Global · White
|
52 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
123 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
175 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
Global · More than one race
|
0 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
Global · Unknown or Not Reported
|
12 Participants
n=165 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
19 Participants
n=336 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
31 Participants
n=501 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
China · American Indian or Alaska Native
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
China · Asian
|
61 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
133 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
194 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
China · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
China · Black or African American
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
China · White
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
|
Race (NIH/OMB)
China · More than one race
|
0 Participants
n=61 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=133 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
0 Participants
n=194 Participants • The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
|
PRIMARY outcome
Timeframe: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
OS was defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Overall Survival (OS) in the Global Population
At CCOD 30 months
|
13.40 months
Interval 11.37 to 16.85
|
19.22 months
Interval 17.02 to 23.66
|
|
Overall Survival (OS) in the Global Population
At CCOD 18 months
|
13.24 months
Interval 10.41 to
NA = not estimable due to the limited number of events observed
|
NA months
NA = not estimable due to the limited number of events observed
|
PRIMARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
|
4.27 months
Interval 3.98 to 5.55
|
6.83 months
Interval 5.75 to 8.28
|
PRIMARY outcome
Timeframe: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
OS was defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Overall Survival (OS) in the China Population
At CCOD 30 months
|
11.37 months
Interval 6.74 to 16.07
|
24.05 months
Interval 17.12 to
NA = not estimable due to the limited number of events observed
|
|
Overall Survival (OS) in the China Population
At CCOD 18 months
|
11.37 months
Interval 6.74 to
NA = not estimable due to the limited number of events observed
|
NA months
Interval 13.5 to
NA = not estimable due to the limited number of events observed
|
PRIMARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
PFS-IRF Per RECIST v1.1 in the China Population
|
3.19 months
Interval 2.56 to 4.76
|
5.72 months
Interval 4.17 to 8.28
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population with measurable disease at baseline consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Outcome measures
| Measure |
Sorafenib - Global
n=159 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=326 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
|
11.9 percentage of participants
Interval 7.35 to 18.03
|
27.3 percentage of participants
Interval 22.54 to 32.48
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population with measurable disease at baseline consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Outcome measures
| Measure |
Sorafenib - Global
n=158 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=325 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
|
13.3 percentage of participants
Interval 8.42 to 19.6
|
33.2 percentage of participants
Interval 28.13 to 38.64
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population with measurable disease at baseline consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Outcome measures
| Measure |
Sorafenib - Global
n=164 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
|
5.5 percentage of participants
Interval 2.54 to 10.16
|
25.6 percentage of participants
Interval 21.01 to 30.61
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: The analysis population included Global participants with a confirmed response (CR or PR).
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Outcome measures
| Measure |
Sorafenib - Global
n=19 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=89 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
|
6.28 months
Interval 4.67 to
NA = not estimable due to the limited number of events observed
|
NA months
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: The analysis population included Global participants with a confirmed response (CR or PR).
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Outcome measures
| Measure |
Sorafenib - Global
n=21 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=108 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
|
6.28 months
Interval 4.86 to
NA = not estimable due to the limited number of events observed
|
NA months
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: The analysis population included Global participants with a confirmed response (CR or PR).
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Outcome measures
| Measure |
Sorafenib - Global
n=9 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=86 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
|
NA months
Interval 5.39 to
NA = not estimable due to the limited number of events observed
|
13.08 months
Interval 13.08 to
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
PFS-IRF Per HCC mRECIST in the Global Population
|
4.24 months
Interval 3.98 to 5.45
|
6.83 months
Interval 5.72 to 7.69
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
|
2.89 months
Interval 2.76 to 4.17
|
7.06 months
Interval 5.68 to 8.44
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
|
5.59 months
Interval 4.21 to 7.72
|
8.57 months
Interval 6.83 to 9.86
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
TTP-IRF Per HCC mRECIST in the Global Population
|
5.55 months
Interval 4.21 to 7.69
|
8.28 months
Interval 6.8 to 9.86
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
|
3.98 months
Interval 2.83 to 4.3
|
8.54 months
Interval 6.93 to 9.92
|
SECONDARY outcome
Timeframe: From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Overall Survival by Baseline AFP in the Global Population
AFP <400 ng/mL
|
13.93 months
Interval 11.73 to
NA = not estimable due to the limited number of events observed
|
NA months
NA = not estimable due to the limited number of events observed
|
|
Overall Survival by Baseline AFP in the Global Population
AFP >/=400 ng/mL
|
9.10 months
Interval 5.75 to
NA = not estimable due to the limited number of events observed
|
12.78 months
Interval 10.15 to
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
AFP <400 ng/mL
|
4.40 months
Interval 4.01 to 6.21
|
8.28 months
Interval 6.83 to 11.04
|
|
PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
AFP >/=400 ng/mL
|
4.14 months
Interval 2.76 to 5.26
|
5.19 months
Interval 3.94 to 6.77
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
AFP <400 ng/mL
|
3.98 months
Interval 2.79 to 5.62
|
8.41 months
Interval 7.06 to 9.66
|
|
PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
AFP >/=400 ng/mL
|
2.79 months
Interval 1.58 to 3.98
|
5.42 months
Interval 4.17 to 6.9
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
Outcome measures
| Measure |
Sorafenib - Global
n=165 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=336 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Time to Deterioration (TTD) in the Global Population
GHS/QoL
|
3.58 months
Interval 3.02 to 6.97
|
11.24 months
Interval 5.98 to
NA = not estimable due to the limited number of events observed
|
|
Time to Deterioration (TTD) in the Global Population
Physical Functioning
|
4.86 months
Interval 3.48 to 6.24
|
13.14 months
Interval 9.69 to
NA = not estimable due to the limited number of events observed
|
|
Time to Deterioration (TTD) in the Global Population
Role Functioning
|
3.58 months
Interval 2.2 to 5.98
|
9.13 months
Interval 6.51 to
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Up to end of study (up to approximately 56 months)Population: Global safety population included all randomized Global participants who received any amount of study drug with participants grouped according to the treatment the participant actually received.
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Sorafenib - Global
n=156 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=329 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) in the Global Population
|
154 Participants
|
322 Participants
|
SECONDARY outcome
Timeframe: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)Population: The Global pharmacokinetic (PK)-evaluable population was defined as all participants in the Global population who received any dose of study treatment and who had at least one post-baseline PK sample available.
Outcome measures
| Measure |
Sorafenib - Global
n=309 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
|
398 micrograms/milliliter (mcg/mL)
Standard Deviation 132
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)Population: The Global pharmacokinetic (PK)-evaluable population was defined as all participants in the Global population who received any dose of study treatment and who had at least one post-baseline PK sample available.
Outcome measures
| Measure |
Sorafenib - Global
n=329 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Pre-dose Cycle 2, Day 1
|
79.2 mcg/mL
Standard Deviation 50.2
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Pre-dose Cycle 3, Day 1
|
101 mcg/mL
Standard Deviation 55.4
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Pre-dose Cycle 4, Day 1
|
131 mcg/mL
Standard Deviation 63.7
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Pre-dose Cycle 8, Day 1
|
145 mcg/mL
Standard Deviation 61.7
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Pre-dose Cycle 12, Day 1
|
168 mcg/mL
Standard Deviation 82.9
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Pre-dose Cycle 16, Day 1
|
167 mcg/mL
Standard Deviation 65.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)Population: The Global ADA-evaluable population was defined as all participants in the Global population who received any dose of atezolizumab and who had at least one post-baseline ADA assessment.
Outcome measures
| Measure |
Sorafenib - Global
n=329 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
Baseline
|
2.2 percentage of participants
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
Post-baseline
|
29.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population with measurable disease at baseline consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Outcome measures
| Measure |
Sorafenib - Global
n=60 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=130 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
|
6.7 percentage of participants
Interval 1.85 to 16.2
|
24.6 percentage of participants
Interval 17.49 to 32.94
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population with measurable disease at baseline consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Outcome measures
| Measure |
Sorafenib - Global
n=59 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=128 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
|
8.5 percentage of participants
Interval 2.81 to 18.68
|
29.7 percentage of participants
Interval 21.94 to 38.4
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population with measurable disease at baseline consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
|
4.9 percentage of participants
Interval 1.03 to 13.71
|
21.1 percentage of participants
Interval 14.47 to 28.97
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: The analysis population included China participants with a confirmed response (CR or PR).
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Outcome measures
| Measure |
Sorafenib - Global
n=4 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=32 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
|
NA months
Interval 4.86 to
NA = not estimable due to the limited number of events observed
|
NA months
Interval 8.15 to
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: The analysis population included China participants with a confirmed response (CR or PR).
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Outcome measures
| Measure |
Sorafenib - Global
n=5 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=38 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
|
4.86 months
Interval 4.47 to
NA = not estimable due to the limited number of events observed
|
NA months
Interval 8.15 to
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)Population: The analysis population included China participants with a confirmed response (CR or PR).
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
Outcome measures
| Measure |
Sorafenib - Global
n=3 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=28 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
|
5.55 months
Interval 4.17 to
NA = not estimable due to the limited number of events observed
|
NA months
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
PFS-IRF Per HCC mRECIST in the China Population
|
3.19 months
Interval 2.56 to 4.76
|
5.72 months
Interval 4.17 to 8.11
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
|
2.83 months
Interval 2.73 to 3.98
|
5.55 months
Interval 4.21 to 8.34
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
|
4.14 months
Interval 2.76 to 10.15
|
7.00 months
Interval 5.45 to 9.49
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
TTP-IRF Per HCC mRECIST in the China Population
|
4.14 months
Interval 2.76 to 10.15
|
7.00 months
Interval 5.45 to 9.49
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
|
2.83 months
Interval 2.79 to 4.17
|
6.83 months
Interval 5.32 to 9.33
|
SECONDARY outcome
Timeframe: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)Population: China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
Outcome measures
| Measure |
Sorafenib - Global
n=61 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=133 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Time to Deterioration (TTD) in the China Population
Physical Functioning
|
5.62 months
Interval 2.1 to
NA = not estimable due to the limited number of events observed
|
13.14 months
Interval 9.69 to
NA = not estimable due to the limited number of events observed
|
|
Time to Deterioration (TTD) in the China Population
Role Functioning
|
NA months
Interval 2.14 to
NA = not estimable due to the limited number of events observed
|
NA months
Interval 7.2 to
NA = not estimable due to the limited number of events observed
|
|
Time to Deterioration (TTD) in the China Population
GHS/QoL
|
3.58 months
Interval 1.48 to 9.82
|
9.76 months
Interval 6.24 to
NA = not estimable due to the limited number of events observed
|
SECONDARY outcome
Timeframe: Up to end of study (up to approximately 56 months)Population: China safety population included all randomized China participants who received any amount of study drug with participants grouped according to the treatment the participant actually received.
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Sorafenib - Global
n=58 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=132 Participants
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) in the China Population
|
56 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)Population: The China PK-evaluable population was defined as all participants in the China population who received any dose of study treatment and who had at least one post-baseline PK sample available.
Outcome measures
| Measure |
Sorafenib - Global
n=85 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
|
456 mcg/mL
Standard Deviation 153
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)Population: The China PK-evaluable population was defined as all participants in the China population who received any dose of study treatment and who had at least one post-baseline PK sample available.
Outcome measures
| Measure |
Sorafenib - Global
n=132 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Pre-dose Cycle 2, Day 1
|
92.6 mcg/mL
Standard Deviation 65.7
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Pre-dose Cycle 3, Day 1
|
105 mcg/mL
Standard Deviation 36.8
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Pre-dose Cycle 4, Day 1
|
143 mcg/mL
Standard Deviation 61.4
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Pre-dose Cycle 8, Day 1
|
177 mcg/mL
Standard Deviation 61.9
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Pre-dose Cycle 12, Day 1
|
201 mcg/mL
Standard Deviation 97.6
|
—
|
|
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Pre-dose Cycle 16, Day 1
|
208 mcg/mL
Standard Deviation 79.4
|
—
|
SECONDARY outcome
Timeframe: Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)Population: The China ADA-evaluable population was defined as all participants in the China population who received any dose of atezolizumab and who had at least one post-baseline ADA assessment.
Outcome measures
| Measure |
Sorafenib - Global
n=132 Participants
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
Baseline
|
1.1 percentage of participants
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
Post-baseline
|
20.2 percentage of participants
|
—
|
Adverse Events
Sorafenib - Global
Serious events: 51 serious events
Other events: 147 other events
Deaths: 115 deaths
Atezolizumab + Bevacizumab - Global
Serious events: 171 serious events
Other events: 311 other events
Deaths: 228 deaths
Sorafenib - China
Serious events: 12 serious events
Other events: 55 other events
Deaths: 46 deaths
Atezolizumab + Bevacizumab - China
Serious events: 54 serious events
Other events: 129 other events
Deaths: 88 deaths
Serious adverse events
| Measure |
Sorafenib - Global
n=156 participants at risk
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=329 participants at risk
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Sorafenib - China
n=58 participants at risk
Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - China
n=132 participants at risk
Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
General physical health deterioration
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Pyrexia
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.3%
11/329 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
4/132 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Cholangitis
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.8%
5/132 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Liver injury
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Burkholderia pseudomallei infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Cellulitis
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Device related infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Empyema
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Hepatitis E
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Herpes simplex encephalitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Peritonsillar abscess
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Pneumonia
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
5/329 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.3%
3/132 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Sepsis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.4%
8/329 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Septic shock
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Skin infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Fall
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Amylase increased
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Aspartate aminotransferase increased
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
5/329 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.3%
3/132 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Cardiac arrest
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Cardiac failure
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/156 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Anal fissure
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Ascites
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.0%
13/329 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.5%
6/132 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Colitis
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
5/329 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
5/329 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
3/156 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.3%
11/329 • Number of events 11 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.3%
3/132 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Lipase increased
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
10/329 • Number of events 12 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
5/329 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.8%
5/132 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Death
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Blood bilirubin increased
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.1%
7/329 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
General physical condition abnormal
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Granulocyte count decreased
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Liver function test increased
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Platelet count decreased
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Encephalopathy
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.9%
3/156 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
5/329 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Syncope
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Renal failure
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Renal haematoma
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.64%
1/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Embolism
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Hypertension
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Hypotension
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Phlebitis
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/329 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Eye disorders
Cataract
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Oedema peripheral
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
COVID-19
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.61%
2/329 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Reproductive system and breast disorders
Scrotal dermatitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/132 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.30%
1/329 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
Other adverse events
| Measure |
Sorafenib - Global
n=156 participants at risk
Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - Global
n=329 participants at risk
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Sorafenib - China
n=58 participants at risk
Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
Atezolizumab + Bevacizumab - China
n=132 participants at risk
Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.0%
14/156 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
11.6%
38/329 • Number of events 56 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
13.8%
8/58 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
19.7%
26/132 • Number of events 44 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.6%
4/156 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.4%
21/329 • Number of events 33 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.9%
4/58 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
14.4%
19/132 • Number of events 32 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
4/156 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
20/329 • Number of events 28 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.1%
12/132 • Number of events 20 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
7/156 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.7%
32/329 • Number of events 45 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
16.7%
22/132 • Number of events 41 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
3/156 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.6%
35/329 • Number of events 41 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
11.4%
15/132 • Number of events 19 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
5/156 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
7.9%
26/329 • Number of events 27 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.9%
4/58 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
16/132 • Number of events 17 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.3%
27/156 • Number of events 31 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.2%
50/329 • Number of events 63 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.2%
10/58 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
14.4%
19/132 • Number of events 24 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
9/156 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
20/329 • Number of events 30 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.9%
4/58 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.3%
7/132 • Number of events 8 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Ascites
|
5.1%
8/156 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.4%
31/329 • Number of events 36 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.8%
9/132 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Constipation
|
16.0%
25/156 • Number of events 27 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.6%
58/329 • Number of events 63 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
13.6%
18/132 • Number of events 20 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.6%
79/156 • Number of events 107 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
22.8%
75/329 • Number of events 109 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
44.8%
26/58 • Number of events 38 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.2%
20/132 • Number of events 28 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Nausea
|
16.0%
25/156 • Number of events 28 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
14.9%
49/329 • Number of events 64 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
7/58 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
13.6%
18/132 • Number of events 22 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Stomatitis
|
4.5%
7/156 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.8%
19/329 • Number of events 21 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
4/132 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
14/156 • Number of events 14 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.3%
34/329 • Number of events 49 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
11.4%
15/132 • Number of events 25 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Asthenia
|
13.5%
21/156 • Number of events 23 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.5%
28/329 • Number of events 40 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.3%
11/132 • Number of events 12 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Fatigue
|
19.2%
30/156 • Number of events 32 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
23.1%
76/329 • Number of events 92 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.3%
6/58 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.9%
17/132 • Number of events 22 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Oedema peripheral
|
3.8%
6/156 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
13.7%
45/329 • Number of events 55 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.8%
13/132 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Pyrexia
|
9.6%
15/156 • Number of events 22 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.6%
58/329 • Number of events 83 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.3%
6/58 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.4%
23/132 • Number of events 32 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
4/156 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
20/329 • Number of events 26 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.3%
7/132 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
2/156 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
7.3%
24/329 • Number of events 27 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
16.7%
22/132 • Number of events 26 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.0%
33/329 • Number of events 40 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.8%
13/132 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Alanine aminotransferase increased
|
9.0%
14/156 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.0%
56/329 • Number of events 80 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
20.7%
12/58 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
22.7%
30/132 • Number of events 52 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Aspartate aminotransferase increased
|
17.9%
28/156 • Number of events 32 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
23.4%
77/329 • Number of events 116 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
32.8%
19/58 • Number of events 23 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
31.1%
41/132 • Number of events 76 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
11/156 • Number of events 12 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.0%
33/329 • Number of events 43 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
7/58 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
14.4%
19/132 • Number of events 29 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Blood bilirubin increased
|
14.7%
23/156 • Number of events 27 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.9%
59/329 • Number of events 114 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
24.1%
14/58 • Number of events 16 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
26.5%
35/132 • Number of events 86 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Blood creatinine increased
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
20/329 • Number of events 32 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
7.6%
10/132 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Platelet count decreased
|
11.5%
18/156 • Number of events 22 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
14.6%
48/329 • Number of events 87 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.2%
10/58 • Number of events 11 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
20.5%
27/132 • Number of events 65 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Weight decreased
|
9.6%
15/156 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.2%
50/329 • Number of events 55 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.3%
6/58 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.9%
21/132 • Number of events 23 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
White blood cell count decreased
|
5.8%
9/156 • Number of events 24 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.4%
21/329 • Number of events 76 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.5%
9/58 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
17.4%
23/132 • Number of events 83 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
39/156 • Number of events 50 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
20.7%
68/329 • Number of events 78 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
20.7%
12/58 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
20.5%
27/132 • Number of events 32 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
4/156 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
7.0%
23/329 • Number of events 40 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.8%
13/132 • Number of events 30 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
11/156 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.8%
42/329 • Number of events 53 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 8 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
24.2%
32/132 • Number of events 44 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
11/156 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.0%
13/329 • Number of events 19 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
19.0%
11/58 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.8%
13/132 • Number of events 22 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.5%
7/156 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
7.9%
26/329 • Number of events 32 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.9%
4/58 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.8%
9/132 • Number of events 16 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
11/156 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.7%
9/329 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.3%
6/58 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.3%
3/132 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
9/156 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
18.8%
62/329 • Number of events 73 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
16/132 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
6/156 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.2%
27/329 • Number of events 30 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.3%
11/132 • Number of events 11 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
5/156 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
20/329 • Number of events 24 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
4/132 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Nervous system disorders
Headache
|
7.1%
11/156 • Number of events 14 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.6%
35/329 • Number of events 44 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.6%
14/132 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Psychiatric disorders
Insomnia
|
7.1%
11/156 • Number of events 11 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
11.9%
39/329 • Number of events 41 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.3%
11/132 • Number of events 12 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
13/156 • Number of events 19 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
32.5%
107/329 • Number of events 184 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
19.0%
11/58 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
51.5%
68/132 • Number of events 120 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
15/156 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
14.0%
46/329 • Number of events 56 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.6%
14/132 • Number of events 19 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.1%
11/156 • Number of events 11 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.4%
31/329 • Number of events 35 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.5%
6/132 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
5/156 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.5%
28/329 • Number of events 29 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.8%
5/132 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
6/156 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
11.2%
37/329 • Number of events 45 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.1%
12/132 • Number of events 12 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.1%
22/156 • Number of events 22 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.8%
6/329 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
7/58 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
48.7%
76/156 • Number of events 82 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.8%
6/329 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
56.9%
33/58 • Number of events 39 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.5%
2/132 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
15/156 • Number of events 16 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
21.6%
71/329 • Number of events 99 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
7/58 • Number of events 8 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
18.2%
24/132 • Number of events 31 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.9%
28/156 • Number of events 28 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
14.0%
46/329 • Number of events 51 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
7/58 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.9%
21/132 • Number of events 24 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Vascular disorders
Hypertension
|
24.4%
38/156 • Number of events 43 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
35.9%
118/329 • Number of events 191 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
20.7%
12/58 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
40.9%
54/132 • Number of events 90 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
17/329 • Number of events 20 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.8%
9/132 • Number of events 11 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.3%
11/329 • Number of events 14 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.8%
9/132 • Number of events 12 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Malaise
|
3.2%
5/156 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.0%
13/329 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.5%
6/132 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
General disorders
Pain
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.7%
9/329 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.8%
9/132 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.6%
4/156 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.4%
8/329 • Number of events 8 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
8/132 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Bilirubin conjugated increased
|
2.6%
4/156 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.6%
12/329 • Number of events 28 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
10.3%
6/58 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
9.8%
13/132 • Number of events 29 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.1%
7/329 • Number of events 19 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.4%
2/58 • Number of events 2 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.3%
7/132 • Number of events 19 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.5%
7/156 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
10/329 • Number of events 14 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.5%
9/58 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
7.6%
10/132 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
10/329 • Number of events 16 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.3%
11/132 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.5%
7/156 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.3%
11/329 • Number of events 13 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
15.5%
9/58 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
12.1%
16/132 • Number of events 18 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Lymphocyte count decreased
|
1.3%
2/156 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.6%
15/329 • Number of events 25 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.8%
9/132 • Number of events 17 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Neutrophil count decreased
|
3.2%
5/156 • Number of events 15 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.9%
16/329 • Number of events 46 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
13.6%
18/132 • Number of events 56 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Protein urine present
|
2.6%
4/156 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.91%
3/329 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
8.6%
5/58 • Number of events 5 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.8%
5/132 • Number of events 9 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Investigations
Prothrombin time prolonged
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.8%
6/329 • Number of events 7 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.3%
7/132 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.64%
1/156 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.7%
1/58 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
8/132 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
6/156 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
10/329 • Number of events 10 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.3%
3/132 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Cylindruria
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.1%
7/329 • Number of events 20 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
8/132 • Number of events 21 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/156 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
4.0%
13/329 • Number of events 25 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.00%
0/58 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
6.1%
8/132 • Number of events 19 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
4/156 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
1.2%
4/329 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
0.76%
1/132 • Number of events 1 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
5/156 • Number of events 6 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
3.0%
10/329 • Number of events 11 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
5.2%
3/58 • Number of events 4 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
2.3%
3/132 • Number of events 3 • Up to end of study (up to approximately 56 months)
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER