Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) (NCT NCT02420821)
NCT ID: NCT02420821
Last Updated: 2023-01-30
Results Overview
Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (\>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 millimeters (mm); \>/=1 new lesion(s); and/or unequivocal progression of existing non-TLs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
915 participants
Primary outcome timeframe
Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
Results posted on
2023-01-30
Participant Flow
A total of 1228 participants were screened, out of which, 915 participants were enrolled into the study.
Participant milestones
| Measure |
Sunitinib
Participants received sunitinib at a dose of 50 milligrams (mg) administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD) as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 milligrams per kilogram (mg/kg) administered via intravenous (IV) infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Overall Study
STARTED
|
461
|
454
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
460
|
453
|
Reasons for withdrawal
| Measure |
Sunitinib
Participants received sunitinib at a dose of 50 milligrams (mg) administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD) as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 milligrams per kilogram (mg/kg) administered via intravenous (IV) infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Non-compliance
|
0
|
2
|
|
Overall Study
Physician Decision
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
32
|
25
|
|
Overall Study
Death
|
270
|
263
|
|
Overall Study
Study Terminated By Sponsor
|
145
|
149
|
|
Overall Study
Patient refused end of treatment visit due to Covid-19
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protinuria
|
0
|
1
|
|
Overall Study
Progressive Disease
|
1
|
1
|
|
Overall Study
Disease Progression
|
0
|
1
|
|
Overall Study
Patient missing record of discontinuation from Atezo.
|
0
|
1
|
Baseline Characteristics
A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
Baseline characteristics by cohort
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Total
n=915 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
61.6 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
60.7 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
352 Participants
n=99 Participants
|
317 Participants
n=107 Participants
|
669 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
386 Participants
n=99 Participants
|
391 Participants
n=107 Participants
|
777 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
77 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
334 Participants
n=99 Participants
|
326 Participants
n=107 Participants
|
660 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the PD-L1-Selected Population, which included all participants in the ITT population whose PD-L1 status was immune cell (IC)1/2/3 at the time of randomization.
Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (\>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 millimeters (mm); \>/=1 new lesion(s); and/or unequivocal progression of existing non-TLs.
Outcome measures
| Measure |
Sunitinib
n=184 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=178 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population
|
69.6 percentage of participants
|
58.4 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the PD-L1-Selected Population.
PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed \>/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=184 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=178 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population
|
7.5 months
Interval 6.8 to 9.7
|
11.2 months
Interval 8.6 to 14.3
|
PRIMARY outcome
Timeframe: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)Population: Analysis was performed on the ITT Population.
Percentage of participants who died of any cause was reported.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Died of Any Cause in ITT Population
|
55.3 percentage of participants
|
54.8 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)Population: Analysis was performed on the ITT Population.
OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Overall Survival (OS) in ITT Population
|
35.3 months
Interval 28.6 to 42.1
|
36.1 months
Interval 31.5 to 42.3
|
SECONDARY outcome
Timeframe: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)Population: Analysis was performed on the PD-L1-Selected Population.
Percentage of participants who died of any cause was reported.
Outcome measures
| Measure |
Sunitinib
n=184 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=178 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population
|
56.5 percentage of participants
|
53.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)Population: Analysis was performed on the PD-L1-Selected Population.
OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=184 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=178 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
OS in PD-L1-Selected Population
|
31.6 months
Interval 23.3 to 42.1
|
38.7 months
Interval 29.0 to 49.7
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population.
Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population
|
63.6 percentage of participants
|
60.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population.
PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
PFS as Determined by an IRC According to RECIST v1.1 in ITT Population
|
8.3 months
Interval 7.0 to 9.7
|
9.6 months
Interval 8.3 to 11.5
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the PD-L1-Selected Population.
Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Outcome measures
| Measure |
Sunitinib
n=184 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=178 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population
|
64.7 percentage of participants
|
62.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the PD-L1-Selected Population.
PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=184 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=178 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population
|
7.2 months
Interval 6.1 to 11.1
|
8.9 months
Interval 6.9 to 12.5
|
SECONDARY outcome
Timeframe: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ORR-Evaluable Population, which included all participants in the ITT population with measurable disease at baseline, as determined by the investigator.
Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to less than (\<) 10 mm. PR was defined as \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
Outcome measures
| Measure |
Sunitinib
n=460 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population
|
33.3 percentage of participants
Interval 28.97 to 37.77
|
36.6 percentage of participants
Interval 32.12 to 41.18
|
SECONDARY outcome
Timeframe: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on DOR-Evaluable Population, which included all participants with a CR/PR in the ORR-Evaluable Population.
DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to \<10 mm. PR: \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=153 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=166 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population
|
14.2 months
Interval 11.3 to
Upper limit of 95% CI could not be estimated due to high number of censored participants.
|
16.6 months
Interval 15.4 to
Upper limit of 95% CI could not be estimated due to high number of censored participants.
|
SECONDARY outcome
Timeframe: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ORR-Evaluable Population.
Tumor response was assessed by an IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to \<10 mm. PR was defined as \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
Outcome measures
| Measure |
Sunitinib
n=460 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population
|
31.3 percentage of participants
Interval 27.09 to 35.76
|
33.3 percentage of participants
Interval 28.94 to 37.8
|
SECONDARY outcome
Timeframe: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the DOR-Evaluable Population.
DOR was defined as the time from the first occurrence of CR/PR to PD as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to \<10 mm. PR: \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=144 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=151 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population
|
18.6 months
Interval 13.8 to
Upper limit of 95% CI could not be estimated due to high number of censored participants.
|
NA months
Interval 16.8 to
Median and Upper limit of 95% CI could not be estimated due to high number of censored participants.
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population.
Tumor response was assessed by the investigator according to immune-modified RECIST. PD was defined as \>/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population
|
58.1 percentage of participants
|
55.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population.
PFS was defined as the time from randomization to PD, as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population
|
12.3 months
Interval 9.8 to 13.7
|
13.9 months
Interval 12.5 to 15.3
|
SECONDARY outcome
Timeframe: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ORR-Evaluable Population.
Tumor response was assessed by the investigator according to immune-modified RECIST. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs or reduction in short axis of any pathological lymph nodes to \<10 mm. PR was defined as \>/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
Outcome measures
| Measure |
Sunitinib
n=460 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population
|
35.0 percentage of participants
Interval 30.64 to 39.55
|
40.1 percentage of participants
Interval 35.55 to 44.76
|
SECONDARY outcome
Timeframe: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on DOR-Evaluable Population.
DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs or reduction in short axis of any pathological lymph nodes to \<10 mm. PR: \>/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. PD: \>/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=161 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=182 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population
|
19.4 months
Interval 13.1 to 20.0
|
19.4 months
Interval 16.5 to
Upper limit of 95% CI could not be estimated due to high number of censored participants.
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population.
Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population
|
63.8 percentage of participants
|
60.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population.
PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed \>/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=461 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=454 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population
|
8.4 months
Interval 7.5 to 9.7
|
11.2 months
Interval 9.6 to 13.6
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population participants with sarcomatoid histology (defined by investigator-assessed conventional histopathology).
Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=68 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology
|
85.1 percentage of participants
|
67.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)Population: Analysis was performed on the ITT Population participants with sarcomatoid histology.
PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=68 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology
|
5.3 months
Interval 3.3 to 6.7
|
8.3 months
Interval 5.4 to 12.9
|
SECONDARY outcome
Timeframe: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)Population: Analysis was performed on the ITT Population participants with sarcomatoid histology.
Percentage of participants with sarcomatoid histology who died of any cause was reported.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=68 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology
|
77.0 percentage of participants
|
64.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)Population: Analysis was performed on the ITT Population participants with sarcomatoid histology.
OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Sunitinib
n=74 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=68 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
OS in Participants With Sarcomatoid Histology
|
15.4 months
Interval 10.4 to 19.5
|
21.7 months
Interval 15.3 to 35.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 daysPopulation: Analysis was performed on the patient-reported outcome (PRO)-Evaluable Population, which included all participants with a non-missing baseline PRO assessment and \>/=1 post-baseline PRO assessment.
The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part II, participants were asked to rate how much the symptoms have interfered with 6 areas of function (general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely) and total Part II score was calculated as an average of 6-item scores. Repeated measures model-estimated least-squares (LS) mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. Here, 'Number Analyzed' = number of participants evaluable at specified time point.
Outcome measures
| Measure |
Sunitinib
n=359 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=373 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 4 Day 1
|
1.02 units on a scale
Standard Error 0.14
|
0.59 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 4 Day 22
|
1.55 units on a scale
Standard Error 0.14
|
0.57 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 6 Day 22
|
1.44 units on a scale
Standard Error 0.15
|
0.80 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 7 Day 1
|
1.15 units on a scale
Standard Error 0.16
|
0.72 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 8 Day 22
|
1.34 units on a scale
Standard Error 0.17
|
0.69 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 9 Day 1
|
1.05 units on a scale
Standard Error 0.17
|
0.67 units on a scale
Standard Error 0.16
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 11 Day 1
|
1.12 units on a scale
Standard Error 0.19
|
0.62 units on a scale
Standard Error 0.17
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 11 Day 22
|
1.45 units on a scale
Standard Error 0.21
|
0.61 units on a scale
Standard Error 0.18
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 12 Day 22
|
1.45 units on a scale
Standard Error 0.24
|
0.69 units on a scale
Standard Error 0.20
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 13 Day 1
|
0.79 units on a scale
Standard Error 0.24
|
0.80 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 14 Day 1
|
0.86 units on a scale
Standard Error 0.27
|
0.73 units on a scale
Standard Error 0.24
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 15 Day 1
|
0.93 units on a scale
Standard Error 0.31
|
0.78 units on a scale
Standard Error 0.27
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 15 Day 22
|
1.67 units on a scale
Standard Error 0.37
|
0.88 units on a scale
Standard Error 0.29
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 16 Day 1
|
0.90 units on a scale
Standard Error 0.38
|
0.98 units on a scale
Standard Error 0.32
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 16 Day 22
|
1.30 units on a scale
Standard Error 0.43
|
1.32 units on a scale
Standard Error 0.36
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 17 Day 1
|
0.80 units on a scale
Standard Error 0.46
|
1.18 units on a scale
Standard Error 0.40
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 18 Day 1
|
0.75 units on a scale
Standard Error 0.64
|
0.75 units on a scale
Standard Error 0.53
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 18 Day 22
|
0.65 units on a scale
Standard Error 0.86
|
0.87 units on a scale
Standard Error 0.63
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 19 Day 1
|
0.29 units on a scale
Standard Error 1.58
|
0.80 units on a scale
Standard Error 0.73
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 19 Day 22
|
—
|
0.88 units on a scale
Standard Error 1.03
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle1 Day 22
|
1.28 units on a scale
Standard Error 0.13
|
0.54 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 2 Day 1
|
0.76 units on a scale
Standard Error 0.13
|
0.56 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 2 Day 22
|
1.58 units on a scale
Standard Error 0.13
|
0.56 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 3 Day 1
|
1.05 units on a scale
Standard Error 0.13
|
0.53 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 3 Day 22
|
1.63 units on a scale
Standard Error 0.14
|
0.61 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 5 Day 1
|
1.18 units on a scale
Standard Error 0.15
|
0.72 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 5 Day 22
|
1.56 units on a scale
Standard Error 0.15
|
0.78 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 6 Day 1
|
1.03 units on a scale
Standard Error 0.15
|
0.82 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 7 Day 22
|
1.43 units on a scale
Standard Error 0.16
|
0.66 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 8 Day 1
|
1.06 units on a scale
Standard Error 0.16
|
0.76 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 9 Day 22
|
1.46 units on a scale
Standard Error 0.18
|
0.56 units on a scale
Standard Error 0.16
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 10 Day 1
|
1.24 units on a scale
Standard Error 0.18
|
0.61 units on a scale
Standard Error 0.16
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 10 Day 22
|
1.61 units on a scale
Standard Error 0.20
|
0.60 units on a scale
Standard Error 0.17
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 12 Day 1
|
1.02 units on a scale
Standard Error 0.21
|
0.53 units on a scale
Standard Error 0.18
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 13 Day 22
|
1.09 units on a scale
Standard Error 0.27
|
0.73 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 14 Day 22
|
1.22 units on a scale
Standard Error 0.31
|
0.83 units on a scale
Standard Error 0.25
|
|
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Change at Cycle 17 Day 22
|
0.92 units on a scale
Standard Error 0.53
|
0.95 units on a scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (EoT) visit (up to approximately 27 months)Population: Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when "at their worst" in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement.
Outcome measures
| Measure |
Sunitinib
n=337 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=358 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Pain: Change at EoT
|
1.41 units on a scale
Standard Error 0.15
|
0.92 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Fatigue: Change at EoT
|
1.83 units on a scale
Standard Error 0.15
|
1.20 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Nausea: Change at EoT
|
1.20 units on a scale
Standard Error 0.11
|
0.29 units on a scale
Standard Error 0.11
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Disturbed sleep: Change at EoT
|
0.71 units on a scale
Standard Error 0.14
|
0.19 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Feelings of being distressed: Change at EoT
|
0.82 units on a scale
Standard Error 0.14
|
0.25 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Shortness of breath: Change at EoT
|
1.15 units on a scale
Standard Error 0.13
|
0.58 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Remembering things: Change at EoT
|
0.93 units on a scale
Standard Error 0.12
|
0.60 units on a scale
Standard Error 0.11
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Lack of appetite: Change at EoT
|
1.59 units on a scale
Standard Error 0.14
|
0.40 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Drowsy: Change at EoT
|
1.32 units on a scale
Standard Error 0.14
|
0.79 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Dry mouth: Change at EoT
|
1.67 units on a scale
Standard Error 0.15
|
0.67 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Feeling sad: Change at EoT
|
0.88 units on a scale
Standard Error 0.14
|
0.28 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Vomiting: Change at EoT
|
0.66 units on a scale
Standard Error 0.09
|
0.08 units on a scale
Standard Error 0.09
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Numbness or tingling: Change at EoT
|
1.01 units on a scale
Standard Error 0.12
|
0.67 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Rash/skin changes: Change at EoT
|
2.08 units on a scale
Standard Error 0.13
|
1.00 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Mouth/throat sores: Change at EoT
|
1.76 units on a scale
Standard Error 0.13
|
0.74 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Diarrhea: Change at EoT
|
1.37 units on a scale
Standard Error 0.10
|
0.29 units on a scale
Standard Error 0.10
|
|
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Headache: Change at EoT
|
0.70 units on a scale
Standard Error 0.11
|
0.66 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 daysPopulation: Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.
The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI interference subscale (6 items) assessed the impact of fatigue on global domains (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely). Change from baseline in the mean score of all 6 items at each timepoint is reported, where a negative value indicates improvement.
Outcome measures
| Measure |
Sunitinib
n=368 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=381 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change Within 30 Days of PD
|
1.74 units on a scale
Standard Deviation 2.64
|
0.74 units on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Baseline
|
2.11 units on a scale
Standard Deviation 2.23
|
2.08 units on a scale
Standard Deviation 2.38
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 1 Day 8
|
0.30 units on a scale
Standard Deviation 1.88
|
0.37 units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 1 Day 15
|
1.26 units on a scale
Standard Deviation 2.49
|
1.06 units on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 1 Day 22
|
1.34 units on a scale
Standard Deviation 2.44
|
0.57 units on a scale
Standard Deviation 2.04
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 1 Day 29
|
1.48 units on a scale
Standard Deviation 2.63
|
0.66 units on a scale
Standard Deviation 2.28
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 1 Day 36
|
0.95 units on a scale
Standard Deviation 2.29
|
0.74 units on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 2 Day 1
|
0.38 units on a scale
Standard Deviation 2.03
|
0.43 units on a scale
Standard Deviation 2.09
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 2 Day 8
|
0.63 units on a scale
Standard Deviation 2.17
|
0.68 units on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 2 Day 15
|
1.10 units on a scale
Standard Deviation 2.35
|
0.55 units on a scale
Standard Deviation 2.29
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 2 Day 22
|
1.24 units on a scale
Standard Deviation 2.65
|
0.26 units on a scale
Standard Deviation 2.14
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 2 Day 29
|
1.45 units on a scale
Standard Deviation 2.61
|
0.51 units on a scale
Standard Deviation 2.14
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 2 Day 36
|
1.11 units on a scale
Standard Deviation 2.46
|
0.43 units on a scale
Standard Deviation 2.17
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 3 Day 1
|
0.76 units on a scale
Standard Deviation 2.27
|
0.21 units on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 3 Day 22
|
1.43 units on a scale
Standard Deviation 2.41
|
0.36 units on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 4 Day 1
|
0.76 units on a scale
Standard Deviation 2.27
|
0.38 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 4 Day 22
|
1.47 units on a scale
Standard Deviation 2.60
|
0.44 units on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 5 Day 1
|
1.01 units on a scale
Standard Deviation 2.46
|
0.52 units on a scale
Standard Deviation 2.31
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 5 Day 22
|
1.38 units on a scale
Standard Deviation 2.22
|
0.61 units on a scale
Standard Deviation 2.27
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 6 Day 1
|
0.88 units on a scale
Standard Deviation 2.24
|
0.59 units on a scale
Standard Deviation 2.15
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 6 Day 22
|
1.25 units on a scale
Standard Deviation 2.42
|
0.52 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 7 Day 1
|
0.82 units on a scale
Standard Deviation 2.35
|
0.61 units on a scale
Standard Deviation 2.17
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 7 Day 22
|
1.05 units on a scale
Standard Deviation 2.31
|
0.47 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 8 Day 1
|
0.87 units on a scale
Standard Deviation 2.21
|
0.63 units on a scale
Standard Deviation 2.36
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 10 Day 22
|
1.62 units on a scale
Standard Deviation 2.75
|
0.52 units on a scale
Standard Deviation 1.95
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 12 Day 1
|
0.89 units on a scale
Standard Deviation 2.45
|
0.35 units on a scale
Standard Deviation 1.75
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 13 Day 1
|
0.84 units on a scale
Standard Deviation 2.29
|
0.36 units on a scale
Standard Deviation 1.88
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 14 Day 1
|
0.80 units on a scale
Standard Deviation 2.33
|
0.73 units on a scale
Standard Deviation 1.80
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 14 Day 22
|
0.69 units on a scale
Standard Deviation 2.73
|
0.94 units on a scale
Standard Deviation 1.96
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 15 Day 1
|
0.95 units on a scale
Standard Deviation 2.42
|
0.61 units on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 16 Day 22
|
1.05 units on a scale
Standard Deviation 1.83
|
1.55 units on a scale
Standard Deviation 1.96
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 17 Day 1
|
0.53 units on a scale
Standard Deviation 1.41
|
1.25 units on a scale
Standard Deviation 1.97
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 17 Day 22
|
1.43 units on a scale
Standard Deviation 2.16
|
0.41 units on a scale
Standard Deviation 1.48
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 18 Day 1
|
0.79 units on a scale
Standard Deviation 1.34
|
0.35 units on a scale
Standard Deviation 1.46
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 18 Day 22
|
1.28 units on a scale
Standard Deviation 2.21
|
0.17 units on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 19 Day 1
|
0.00 units on a scale
|
-0.80 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 19 Day 22
|
—
|
-0.25 units on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at 6 weeks after EoT
|
2.31 units on a scale
Standard Deviation 2.52
|
1.83 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at 12 weeks after EoT
|
1.71 units on a scale
Standard Deviation 2.66
|
1.97 units on a scale
Standard Deviation 2.63
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at 24 weeks after EoT
|
2.38 units on a scale
Standard Deviation 3.11
|
2.15 units on a scale
Standard Deviation 3.30
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at 36 weeks after EoT
|
2.40 units on a scale
Standard Deviation 3.32
|
1.15 units on a scale
Standard Deviation 2.72
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at EoT
|
1.57 units on a scale
Standard Deviation 2.80
|
1.62 units on a scale
Standard Deviation 2.98
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 8 Day 22
|
1.22 units on a scale
Standard Deviation 2.21
|
0.52 units on a scale
Standard Deviation 2.05
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 9 Day 1
|
0.93 units on a scale
Standard Deviation 2.25
|
0.57 units on a scale
Standard Deviation 2.27
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 9 Day 22
|
1.35 units on a scale
Standard Deviation 2.37
|
0.37 units on a scale
Standard Deviation 2.15
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 10 Day 1
|
1.09 units on a scale
Standard Deviation 2.53
|
0.56 units on a scale
Standard Deviation 1.96
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 11 Day 1
|
0.95 units on a scale
Standard Deviation 2.29
|
0.60 units on a scale
Standard Deviation 1.92
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 11 Day 22
|
0.88 units on a scale
Standard Deviation 2.57
|
0.57 units on a scale
Standard Deviation 1.78
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 12 Day 22
|
0.97 units on a scale
Standard Deviation 2.46
|
0.58 units on a scale
Standard Deviation 1.96
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 13 Day 22
|
0.76 units on a scale
Standard Deviation 2.70
|
0.56 units on a scale
Standard Deviation 2.06
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 15 Day 22
|
1.05 units on a scale
Standard Deviation 3.22
|
0.91 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Change at Cycle 16 Day 1
|
0.13 units on a scale
Standard Deviation 1.49
|
1.02 units on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 daysPopulation: Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.
The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI worst fatigue item assessed the severity of fatigue at its worst in the last 24 hours. The item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Change from baseline in the score at each time point is reported, where a negative value indicates improvement.
Outcome measures
| Measure |
Sunitinib
n=368 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=381 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 2 Day 36
|
1.09 units on a scale
Standard Deviation 3.01
|
0.48 units on a scale
Standard Deviation 2.76
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 1 Day 15
|
1.32 units on a scale
Standard Deviation 2.82
|
1.26 units on a scale
Standard Deviation 2.92
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 1 Day 22
|
1.52 units on a scale
Standard Deviation 2.86
|
0.49 units on a scale
Standard Deviation 2.30
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 1 Day 29
|
1.55 units on a scale
Standard Deviation 2.99
|
0.88 units on a scale
Standard Deviation 2.62
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 2 Day 15
|
1.09 units on a scale
Standard Deviation 2.82
|
0.71 units on a scale
Standard Deviation 2.78
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 2 Day 22
|
1.42 units on a scale
Standard Deviation 3.01
|
0.31 units on a scale
Standard Deviation 2.53
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 3 Day 22
|
1.57 units on a scale
Standard Deviation 2.98
|
0.57 units on a scale
Standard Deviation 2.64
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 4 Day 22
|
1.46 units on a scale
Standard Deviation 3.14
|
0.58 units on a scale
Standard Deviation 2.74
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 5 Day 1
|
0.81 units on a scale
Standard Deviation 2.75
|
0.62 units on a scale
Standard Deviation 2.79
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 5 Day 22
|
1.60 units on a scale
Standard Deviation 2.87
|
0.69 units on a scale
Standard Deviation 2.83
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 6 Day 1
|
0.90 units on a scale
Standard Deviation 2.78
|
0.86 units on a scale
Standard Deviation 2.73
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 6 Day 22
|
1.35 units on a scale
Standard Deviation 2.79
|
0.53 units on a scale
Standard Deviation 2.66
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 7 Day 1
|
0.79 units on a scale
Standard Deviation 2.78
|
0.79 units on a scale
Standard Deviation 2.70
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 7 Day 22
|
1.22 units on a scale
Standard Deviation 2.85
|
0.65 units on a scale
Standard Deviation 2.56
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 8 Day 1
|
0.79 units on a scale
Standard Deviation 2.69
|
0.75 units on a scale
Standard Deviation 2.84
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 8 Day 22
|
1.40 units on a scale
Standard Deviation 2.64
|
0.78 units on a scale
Standard Deviation 2.67
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 9 Day 1
|
0.97 units on a scale
Standard Deviation 2.54
|
0.61 units on a scale
Standard Deviation 2.62
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 10 Day 1
|
0.95 units on a scale
Standard Deviation 2.73
|
0.69 units on a scale
Standard Deviation 2.46
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 10 Day 22
|
1.74 units on a scale
Standard Deviation 3.09
|
0.63 units on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 11 Day 22
|
1.15 units on a scale
Standard Deviation 3.18
|
0.74 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 12 Day 1
|
0.78 units on a scale
Standard Deviation 2.79
|
0.61 units on a scale
Standard Deviation 2.29
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 12 Day 22
|
1.32 units on a scale
Standard Deviation 2.89
|
0.74 units on a scale
Standard Deviation 2.69
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 13 Day 22
|
0.72 units on a scale
Standard Deviation 3.48
|
0.65 units on a scale
Standard Deviation 2.70
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 15 Day 1
|
0.52 units on a scale
Standard Deviation 3.15
|
0.93 units on a scale
Standard Deviation 2.25
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 16 Day 1
|
-0.05 units on a scale
Standard Deviation 2.61
|
1.33 units on a scale
Standard Deviation 1.92
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 16 Day 22
|
0.77 units on a scale
Standard Deviation 3.70
|
1.68 units on a scale
Standard Deviation 2.10
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 17 Day 1
|
-0.62 units on a scale
Standard Deviation 3.75
|
1.68 units on a scale
Standard Deviation 1.97
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 17 Day 22
|
1.44 units on a scale
Standard Deviation 3.91
|
1.18 units on a scale
Standard Deviation 1.99
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 18 Day 1
|
0.00 units on a scale
Standard Deviation 2.00
|
1.33 units on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 18 Day 22
|
1.00 units on a scale
Standard Deviation 1.73
|
1.00 units on a scale
Standard Deviation 2.10
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 19 Day 1
|
-4.00 units on a scale
|
0.60 units on a scale
Standard Deviation 1.34
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 19 Day 22
|
—
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at 36 weeks after EoT
|
1.86 units on a scale
Standard Deviation 4.37
|
0.78 units on a scale
Standard Deviation 2.86
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at EoT
|
1.40 units on a scale
Standard Deviation 3.13
|
1.72 units on a scale
Standard Deviation 2.84
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change Within 30 Days of PD
|
1.81 units on a scale
Standard Deviation 3.16
|
0.89 units on a scale
Standard Deviation 2.58
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 3 Day 1
|
0.42 units on a scale
Standard Deviation 2.68
|
0.40 units on a scale
Standard Deviation 2.57
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 4 Day 1
|
0.64 units on a scale
Standard Deviation 2.76
|
0.54 units on a scale
Standard Deviation 2.49
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Baseline
|
3.08 units on a scale
Standard Deviation 2.66
|
2.98 units on a scale
Standard Deviation 2.69
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 1 Day 8
|
0.34 units on a scale
Standard Deviation 2.35
|
0.50 units on a scale
Standard Deviation 2.29
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 1 Day 36
|
0.77 units on a scale
Standard Deviation 2.82
|
0.86 units on a scale
Standard Deviation 2.50
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 2 Day 1
|
0.40 units on a scale
Standard Deviation 2.50
|
0.45 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 2 Day 8
|
0.56 units on a scale
Standard Deviation 2.68
|
0.87 units on a scale
Standard Deviation 2.82
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 2 Day 29
|
1.43 units on a scale
Standard Deviation 3.08
|
0.62 units on a scale
Standard Deviation 2.66
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 9 Day 22
|
1.54 units on a scale
Standard Deviation 2.92
|
0.57 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 11 Day 1
|
0.73 units on a scale
Standard Deviation 2.80
|
0.74 units on a scale
Standard Deviation 2.69
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 13 Day 1
|
0.35 units on a scale
Standard Deviation 2.54
|
0.49 units on a scale
Standard Deviation 2.46
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 14 Day 1
|
0.56 units on a scale
Standard Deviation 2.84
|
0.81 units on a scale
Standard Deviation 2.60
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 14 Day 22
|
0.37 units on a scale
Standard Deviation 3.01
|
1.04 units on a scale
Standard Deviation 2.40
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at Cycle 15 Day 22
|
0.59 units on a scale
Standard Deviation 4.08
|
0.97 units on a scale
Standard Deviation 1.84
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at 6 weeks after EoT
|
2.43 units on a scale
Standard Deviation 3.25
|
2.40 units on a scale
Standard Deviation 2.89
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at 12 weeks after EoT
|
1.56 units on a scale
Standard Deviation 3.41
|
2.06 units on a scale
Standard Deviation 3.14
|
|
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Change at 24 weeks after EoT
|
1.58 units on a scale
Standard Deviation 3.82
|
1.92 units on a scale
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 daysPopulation: Analysis was performed on the PRO-Evaluable Population. Here, 'Number Analyzed' = number of participants evaluable at specified time point.
The FKSI-19 is a 19-item tool designed to assess the most important symptoms and concerns related to treatment effectiveness in advanced kidney cancer. The FKSI-19 GP5 item (bothered by the side effect of treatment) assessed side effects burden in the past 7 days on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Repeated measures model-estimated LS mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement.
Outcome measures
| Measure |
Sunitinib
n=359 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
n=373 Participants
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 2 Day 22
|
-1.13 units on a scale
Standard Error 0.06
|
-0.43 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 3 Day 1
|
-1.07 units on a scale
Standard Error 0.06
|
-0.49 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 3 Day 22
|
-1.22 units on a scale
Standard Error 0.06
|
-0.45 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 4 Day 1
|
-1.07 units on a scale
Standard Error 0.06
|
-0.45 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 4 Day 22
|
-1.31 units on a scale
Standard Error 0.07
|
-0.49 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 5 Day 1
|
-1.17 units on a scale
Standard Error 0.07
|
-0.52 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 5 Day 22
|
-1.38 units on a scale
Standard Error 0.07
|
-0.55 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 6 Day 1
|
-1.14 units on a scale
Standard Error 0.07
|
-0.51 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 6 Day 22
|
-1.27 units on a scale
Standard Error 0.07
|
-0.56 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 7 Day 1
|
-1.09 units on a scale
Standard Error 0.07
|
-0.61 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 7 Day 22
|
-1.25 units on a scale
Standard Error 0.07
|
-0.58 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 8 Day 1
|
-1.08 units on a scale
Standard Error 0.08
|
-0.61 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 8 Day 22
|
-1.22 units on a scale
Standard Error 0.08
|
-0.62 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 9 Day 1
|
-1.08 units on a scale
Standard Error 0.08
|
-0.60 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 9 Day 22
|
-1.23 units on a scale
Standard Error 0.08
|
-0.52 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 10 Day 1
|
-1.06 units on a scale
Standard Error 0.08
|
-0.53 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 10 Day 22
|
-1.30 units on a scale
Standard Error 0.09
|
-0.57 units on a scale
Standard Error 0.08
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 11 Day 1
|
-1.16 units on a scale
Standard Error 0.09
|
-0.52 units on a scale
Standard Error 0.08
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 11 Day 22
|
-1.28 units on a scale
Standard Error 0.11
|
-0.54 units on a scale
Standard Error 0.08
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 12 Day 22
|
-1.17 units on a scale
Standard Error 0.12
|
-0.56 units on a scale
Standard Error 0.09
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 13 Day 1
|
-1.15 units on a scale
Standard Error 0.12
|
-0.62 units on a scale
Standard Error 0.10
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 13 Day 22
|
-1.20 units on a scale
Standard Error 0.14
|
-0.64 units on a scale
Standard Error 0.11
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 14 Day 1
|
-0.94 units on a scale
Standard Error 0.14
|
-0.61 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 14 Day 22
|
-1.32 units on a scale
Standard Error 0.16
|
-0.65 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 15 Day 1
|
-0.91 units on a scale
Standard Error 0.15
|
-0.62 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 16 Day 1
|
-1.06 units on a scale
Standard Error 0.19
|
-0.58 units on a scale
Standard Error 0.16
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 16 Day 22
|
-1.34 units on a scale
Standard Error 0.22
|
-0.41 units on a scale
Standard Error 0.18
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 17 Day 1
|
-1.10 units on a scale
Standard Error 0.23
|
-0.56 units on a scale
Standard Error 0.20
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 17 Day 22
|
-1.02 units on a scale
Standard Error 0.27
|
-0.44 units on a scale
Standard Error 0.24
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 18 Day 1
|
-1.01 units on a scale
Standard Error 0.33
|
-0.38 units on a scale
Standard Error 0.27
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 19 Day 1
|
-1.27 units on a scale
Standard Error 0.84
|
-0.75 units on a scale
Standard Error 0.38
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 19 Day 22
|
—
|
-0.93 units on a scale
Standard Error 0.55
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle1 Day 22
|
-1.08 units on a scale
Standard Error 0.06
|
-0.36 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 2 Day 1
|
-0.87 units on a scale
Standard Error 0.06
|
-0.45 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 12 Day 1
|
-1.05 units on a scale
Standard Error 0.10
|
-0.62 units on a scale
Standard Error 0.09
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 15 Day 22
|
-1.16 units on a scale
Standard Error 0.19
|
-0.72 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Change at Cycle 18 Day 22
|
-0.81 units on a scale
Standard Error 0.46
|
-0.48 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)Population: Analysis was performed on the ATA-Evaluable Population, which included all participants in the Atezolizumab + Bevacizumab arm with a non-missing baseline ATA sample and \>/=1 post-baseline ATA sample.
The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against atezolizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint.
Outcome measures
| Measure |
Sunitinib
n=446 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Baseline: ATA Positive Participants
|
16 participants
|
—
|
|
Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Post-Baseline: Treatment-Induced ATA
|
95 participants
|
—
|
|
Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Post-Baseline: Treatment-Enhanced ATA
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)Population: Analysis was performed on the ATA-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint.
The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against bevacizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Outcome measures
| Measure |
Sunitinib
n=444 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Number of Participants With ATAs Against Bevacizumab
Baseline: ATA Positive Participants
|
24 participants
|
—
|
|
Number of Participants With ATAs Against Bevacizumab
Post-Baseline: Treatment-Induced ATA
|
4 participants
|
—
|
|
Number of Participants With ATAs Against Bevacizumab
Post-Baseline: Treatment-Enhanced ATA
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)Population: Analysis was performed on the Atezolizumab Pharmacokinetic (PK) Population, which included all participants who received atezolizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
Cmax for atezolizumab was estimated from plasma concentration versus time data.
Outcome measures
| Measure |
Sunitinib
n=435 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Atezolizumab
|
376 micrograms per milliliter (mcg/mL)
Standard Deviation 90.2
|
—
|
SECONDARY outcome
Timeframe: Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 daysPopulation: Analysis was performed on the Atezolizumab PK Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.
Cmin for atezolizumab was estimated from plasma concentration versus time data.
Outcome measures
| Measure |
Sunitinib
n=426 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Minimum Observed Serum Concentration (Cmin) for Atezolizumab
Cycle 1 Day 22
|
85.6 mcg/mL
Standard Deviation 35.3
|
—
|
|
Minimum Observed Serum Concentration (Cmin) for Atezolizumab
Cycle 2 Day 1
|
127 mcg/mL
Standard Deviation 49.6
|
—
|
SECONDARY outcome
Timeframe: 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)Population: Analysis was performed on the Bevacizumab PK Population, which included all participants who received bevacizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
Cmax for bevacizumab was estimated from plasma concentration versus time data.
Outcome measures
| Measure |
Sunitinib
n=427 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Cmax for Bevacizumab
|
339 mcg/mL
Standard Deviation 104
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days)Population: Analysis was performed on the Bevacizumab PK Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.
Cmin for bevacizumab was estimated from plasma concentration versus time data.
Outcome measures
| Measure |
Sunitinib
n=363 Participants
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Atezolizumab + Bevacizumab
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Cmin for Bevacizumab
|
135 mcg/mL
Standard Deviation 56.1
|
—
|
Adverse Events
Atezolizumab + Bevacizumab
Serious events: 191 serious events
Other events: 437 other events
Deaths: 263 deaths
Sunitinib
Serious events: 169 serious events
Other events: 435 other events
Deaths: 270 deaths
Serious adverse events
| Measure |
Atezolizumab + Bevacizumab
n=451 participants at risk
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Sunitinib
n=446 participants at risk
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.44%
2/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.90%
4/446 • Number of events 5 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
FACTOR VIII INHIBITION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.90%
4/446 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CORONARY ARTERY INSUFFICIENCY
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.0%
9/451 • Number of events 9 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
MYOCARDITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
GLUCOCORTICOID DEFICIENCY
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPOPHYSITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.1%
5/446 • Number of events 5 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.67%
3/446 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
AUTOIMMUNE COLITIS
|
0.22%
1/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
COLITIS
|
0.89%
4/451 • Number of events 5 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.6%
7/451 • Number of events 7 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL FISTULA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ILEUS
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
IMMUNE-MEDIATED ENTEROCOLITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
MECHANICAL ILEUS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.67%
3/446 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
OESOPHAGEAL PERFORATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.3%
6/446 • Number of events 6 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
ASTHENIA
|
0.89%
4/451 • Number of events 5 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.67%
3/446 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
CHEST PAIN
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.90%
4/446 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
CHILLS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
DEATH
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
FATIGUE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.67%
3/446 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
GAIT DISTURBANCE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MALAISE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.22%
1/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PAIN
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PERIPHERAL SWELLING
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PYREXIA
|
2.9%
13/451 • Number of events 14 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.8%
8/446 • Number of events 9 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
CHOLANGITIS ACUTE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
IMMUNE-MEDIATED HEPATITIS
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
LIVER INJURY
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME
|
0.22%
1/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
SYSTEMIC IMMUNE ACTIVATION
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ABSCESS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
APPENDICITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ATYPICAL PNEUMONIA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CAMPYLOBACTER INFECTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CELLULITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
COMPLICATED APPENDICITIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CYSTITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
EMPYEMA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ENCEPHALITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
FEBRILE INFECTION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
HAEMATOMA INFECTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
HERPES ZOSTER
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
INFECTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
INFLUENZA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
MENINGITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
MENINGITIS ASEPTIC
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ORCHITIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PARONYCHIA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PERITONITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PILONIDAL CYST
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PNEUMONIA
|
2.2%
10/451 • Number of events 11 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.3%
6/446 • Number of events 6 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PNEUMONIA ASPIRATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PNEUMONIA MYCOPLASMAL
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PYELONEPHRITIS CHRONIC
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
SCROTAL ABSCESS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
SEPSIS
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
TUBERCULOSIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
UROSEPSIS
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
WOUND INFECTION
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
ACCIDENT AT HOME
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
CONJUNCTIVAL LACERATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL ANASTOMOTIC LEAK
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
INJURY
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
NECK INJURY
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
TOOTH INJURY
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD SODIUM DECREASED
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
LIPASE INCREASED
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
WEIGHT DECREASED
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.89%
4/451 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.6%
7/446 • Number of events 7 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.90%
4/446 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.67%
3/446 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.67%
3/451 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.67%
3/446 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
HAEMATOMA MUSCLE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.89%
4/451 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
SACRAL PAIN
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHOLANGIOCARCINOMA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON NEOPLASM
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GALLBLADDER CANCER
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER STAGE III
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRACRANIAL TUMOUR HAEMORRHAGE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
APHASIA
|
0.22%
1/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CEREBROSPINAL FLUID LEAKAGE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
GLIOSIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HEADACHE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
LETHARGY
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
LUMBOSACRAL PLEXOPATHY
|
0.22%
1/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
PARAPLEGIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
SEIZURE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
THALAMUS HAEMORRHAGE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.45%
2/446 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Product Issues
DEVICE DISLOCATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
2.2%
10/451 • Number of events 10 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.5%
11/446 • Number of events 11 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.90%
4/446 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
NEPHRITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
UROGENITAL HAEMORRHAGE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.89%
4/451 • Number of events 4 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.1%
5/446 • Number of events 6 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL OEDEMA
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.3%
6/451 • Number of events 8 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.1%
5/451 • Number of events 5 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.1%
5/446 • Number of events 5 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY INFARCTION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.22%
1/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
TOXIC EPIDERMAL NECROLYSIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Surgical and medical procedures
HERNIA REPAIR
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
ANEURYSM
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
AORTIC DISORDER
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
AORTIC DISSECTION
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HAEMATOMA
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPERTENSION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPOTENSION
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
SHOCK
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.22%
1/446 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
VASCULITIS
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/446 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
Other adverse events
| Measure |
Atezolizumab + Bevacizumab
n=451 participants at risk
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
Sunitinib
n=446 participants at risk
Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.3%
51/451 • Number of events 81 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
23.3%
104/446 • Number of events 177 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.1%
5/451 • Number of events 13 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.0%
31/446 • Number of events 65 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.1%
5/451 • Number of events 7 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
13.9%
62/446 • Number of events 157 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.3%
15/451 • Number of events 36 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
17.9%
80/446 • Number of events 172 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
6.9%
31/451 • Number of events 32 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.1%
14/446 • Number of events 16 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
24.2%
109/451 • Number of events 123 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
29.1%
130/446 • Number of events 149 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.3%
42/451 • Number of events 51 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.4%
42/446 • Number of events 69 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.9%
22/451 • Number of events 24 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.0%
40/446 • Number of events 67 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
19.1%
86/451 • Number of events 106 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
15.2%
68/446 • Number of events 87 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
33.3%
150/451 • Number of events 273 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
53.6%
239/446 • Number of events 632 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DRY MOUTH
|
8.4%
38/451 • Number of events 52 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.6%
25/446 • Number of events 36 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.5%
34/451 • Number of events 45 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
19.3%
86/446 • Number of events 110 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.3%
15/451 • Number of events 15 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.3%
55/446 • Number of events 65 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
22.2%
100/451 • Number of events 135 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
39.7%
177/446 • Number of events 320 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
11.1%
50/451 • Number of events 67 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
23.1%
103/446 • Number of events 170 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
TOOTHACHE
|
6.7%
30/451 • Number of events 38 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.0%
18/446 • Number of events 20 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
VOMITING
|
13.1%
59/451 • Number of events 106 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
26.9%
120/446 • Number of events 210 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
ASTHENIA
|
18.4%
83/451 • Number of events 142 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
25.3%
113/446 • Number of events 201 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
CHEST PAIN
|
5.1%
23/451 • Number of events 31 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.5%
29/446 • Number of events 30 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
FATIGUE
|
35.9%
162/451 • Number of events 244 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
38.1%
170/446 • Number of events 302 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
9.5%
43/451 • Number of events 73 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.5%
20/446 • Number of events 24 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MUCOSAL INFLAMMATION
|
10.0%
45/451 • Number of events 69 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
29.1%
130/446 • Number of events 233 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
14.4%
65/451 • Number of events 92 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
11.2%
50/446 • Number of events 69 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PAIN
|
5.5%
25/451 • Number of events 27 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.9%
13/446 • Number of events 15 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PYREXIA
|
17.3%
78/451 • Number of events 117 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.6%
56/446 • Number of events 68 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.4%
47/451 • Number of events 67 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.0%
40/446 • Number of events 52 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
RHINITIS
|
5.5%
25/451 • Number of events 33 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.3%
6/446 • Number of events 6 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
SINUSITIS
|
5.1%
23/451 • Number of events 34 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.5%
11/446 • Number of events 12 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
11.5%
52/451 • Number of events 81 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.4%
33/446 • Number of events 38 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.5%
34/451 • Number of events 56 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.4%
24/446 • Number of events 34 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
6.9%
31/451 • Number of events 56 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.5%
38/446 • Number of events 56 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.2%
28/451 • Number of events 45 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.0%
40/446 • Number of events 58 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD CREATININE INCREASED
|
11.1%
50/451 • Number of events 87 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.0%
40/446 • Number of events 79 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.67%
3/451 • Number of events 3 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.3%
28/446 • Number of events 67 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.44%
2/451 • Number of events 2 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.5%
47/446 • Number of events 82 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
WEIGHT DECREASED
|
10.6%
48/451 • Number of events 53 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.8%
26/446 • Number of events 36 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
20.8%
94/451 • Number of events 115 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
33.2%
148/446 • Number of events 213 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.3%
24/451 • Number of events 35 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.8%
17/446 • Number of events 25 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
7.8%
35/451 • Number of events 54 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.0%
18/446 • Number of events 26 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
6.0%
27/451 • Number of events 39 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.3%
19/446 • Number of events 26 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
29.9%
135/451 • Number of events 218 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
17.7%
79/446 • Number of events 95 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
18.2%
82/451 • Number of events 95 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.8%
57/446 • Number of events 76 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
13.5%
61/451 • Number of events 75 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.6%
25/446 • Number of events 32 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.3%
24/451 • Number of events 26 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.2%
10/446 • Number of events 11 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.0%
54/451 • Number of events 88 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.5%
38/446 • Number of events 53 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DIZZINESS
|
12.9%
58/451 • Number of events 73 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.3%
28/446 • Number of events 36 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DYSGEUSIA
|
6.0%
27/451 • Number of events 31 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
21.1%
94/446 • Number of events 129 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HEADACHE
|
24.6%
111/451 • Number of events 175 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
17.5%
78/446 • Number of events 104 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
TASTE DISORDER
|
1.8%
8/451 • Number of events 8 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.3%
37/446 • Number of events 47 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
ANXIETY
|
7.5%
34/451 • Number of events 36 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.4%
15/446 • Number of events 15 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
INSOMNIA
|
10.0%
45/451 • Number of events 48 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.2%
41/446 • Number of events 44 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
4.4%
20/451 • Number of events 33 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.8%
26/446 • Number of events 63 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
PROTEINURIA
|
33.3%
150/451 • Number of events 311 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.3%
37/446 • Number of events 61 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
25.3%
114/451 • Number of events 159 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
22.0%
98/446 • Number of events 120 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
14.6%
66/451 • Number of events 75 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.0%
18/446 • Number of events 19 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
13.3%
60/451 • Number of events 79 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.9%
44/446 • Number of events 62 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
16.9%
76/451 • Number of events 98 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
15.7%
70/446 • Number of events 93 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
9.5%
43/451 • Number of events 53 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.0%
18/446 • Number of events 23 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.1%
32/451 • Number of events 43 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.8%
8/446 • Number of events 8 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
10.4%
47/451 • Number of events 58 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.4%
42/446 • Number of events 47 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
HAIR COLOUR CHANGES
|
0.00%
0/451 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.6%
34/446 • Number of events 36 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
4.2%
19/451 • Number of events 21 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
44.8%
200/446 • Number of events 456 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
25.3%
114/451 • Number of events 170 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.8%
35/446 • Number of events 42 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
22.2%
100/451 • Number of events 151 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
16.4%
73/446 • Number of events 99 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.3%
28/446 • Number of events 37 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
YELLOW SKIN
|
0.22%
1/451 • Number of events 1 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.5%
29/446 • Number of events 42 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPERTENSION
|
40.6%
183/451 • Number of events 304 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
43.3%
193/446 • Number of events 349 • Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
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