Trial Outcomes & Findings for A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL (NCT NCT02970318)
NCT ID: NCT02970318
Last Updated: 2026-02-06
Results Overview
To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis. IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
310 participants
Primary outcome timeframe
IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
Results posted on
2026-02-06
Participant Flow
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia. A total of 310 subjects met the eligibility criteria and were randomized to the acalabrutinib arm (N = 155) and IR/BR arm (N = 155). All but 3 subjects (1 randomized to acalabrutinib and 2 randomized to IR/BR) received study treatment.
310 patients were enrolled in this study and agreed to move forward in participating in the trial.
Participant milestones
| Measure |
Arm A- Acala 100 mg BID- Overall Study Period
Arm A- Acalabrutinib 100 mg BID- Overall Study Period
|
Arm B: Investigator Choice (IR or BR)-Main Study Period
IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
|
Arm B- Inv Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
Arm B- Investigator Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
|
Arm B- Inv. Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
Arm B- Investigator Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
|
|---|---|---|---|---|
|
Overall for Arm A & Main for Arm B
STARTED
|
155
|
155
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
Arm B Treatment= Idelalisib Plus Rituximab
|
0
|
119
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
Arm B Treatment = Bendamustine Plus Rituximab
|
0
|
36
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
Completed
|
99
|
26
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
COMPLETED
|
99
|
27
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
NOT COMPLETED
|
56
|
128
|
0
|
0
|
|
ArmB: Inv.Choice Crossed Over to Acala
STARTED
|
0
|
0
|
63
|
17
|
|
ArmB: Inv.Choice Crossed Over to Acala
COMPLETED
|
0
|
0
|
42
|
14
|
|
ArmB: Inv.Choice Crossed Over to Acala
NOT COMPLETED
|
0
|
0
|
21
|
3
|
Reasons for withdrawal
| Measure |
Arm A- Acala 100 mg BID- Overall Study Period
Arm A- Acalabrutinib 100 mg BID- Overall Study Period
|
Arm B: Investigator Choice (IR or BR)-Main Study Period
IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
|
Arm B- Inv Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
Arm B- Investigator Choice of IR Crossed Over to Arm A- Acala. 100 mg BID
|
Arm B- Inv. Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
Arm B- Investigator Choice of BR Crossed Over to Arm A- Acala. 100 mg BID
|
|---|---|---|---|---|
|
Overall for Arm A & Main for Arm B
Lost to Follow-up
|
2
|
1
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
Withdrawal by Subject
|
13
|
14
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
Death
|
41
|
33
|
0
|
0
|
|
Overall for Arm A & Main for Arm B
Arm B Crossed Over to Arm A Acala 100 mg Monotherapy
|
0
|
80
|
0
|
0
|
|
ArmB: Inv.Choice Crossed Over to Acala
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
ArmB: Inv.Choice Crossed Over to Acala
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
ArmB: Inv.Choice Crossed Over to Acala
Death
|
0
|
0
|
18
|
2
|
Baseline Characteristics
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
Baseline characteristics by cohort
| Measure |
Arm A- Acala. 100 mg BID
n=155 Participants
Arm A- Acalabrutinib 100 mg BID
|
Arm B: Investigator Choice (IR or BR)-Main Study Period
n=155 Participants
IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age < 65 Years
|
58 Participants
n=192 Participants
|
57 Participants
n=170 Participants
|
115 Participants
n=185 Participants
|
|
Age, Customized
Age >=65 years
|
97 Participants
n=192 Participants
|
98 Participants
n=170 Participants
|
195 Participants
n=185 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=192 Participants
|
55 Participants
n=170 Participants
|
102 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=192 Participants
|
100 Participants
n=170 Participants
|
208 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=192 Participants
|
6 Participants
n=170 Participants
|
8 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=192 Participants
|
129 Participants
n=170 Participants
|
276 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=192 Participants
|
20 Participants
n=170 Participants
|
26 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=192 Participants
|
7 Participants
n=170 Participants
|
14 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=192 Participants
|
1 Participants
n=170 Participants
|
1 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
145 Participants
n=192 Participants
|
141 Participants
n=170 Participants
|
286 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=192 Participants
|
6 Participants
n=170 Participants
|
9 Participants
n=185 Participants
|
|
Region of Enrollment
North America
|
8 Participants
n=192 Participants
|
9 Participants
n=170 Participants
|
17 Participants
n=185 Participants
|
|
Region of Enrollment
Australia
|
6 Participants
n=192 Participants
|
6 Participants
n=170 Participants
|
12 Participants
n=185 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=192 Participants
|
1 Participants
n=170 Participants
|
4 Participants
n=185 Participants
|
|
Region of Enrollment
Europe
|
131 Participants
n=192 Participants
|
132 Participants
n=170 Participants
|
263 Participants
n=185 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
1 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
1 Participants
n=185 Participants
|
|
Region of Enrollment
Hong Kong
|
0 Participants
n=192 Participants
|
1 Participants
n=170 Participants
|
1 Participants
n=185 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
3 Participants
n=192 Participants
|
4 Participants
n=170 Participants
|
7 Participants
n=185 Participants
|
|
Region of Enrollment
Singapore
|
3 Participants
n=192 Participants
|
2 Participants
n=170 Participants
|
5 Participants
n=185 Participants
|
PRIMARY outcome
Timeframe: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-upPopulation: Intent-to-treat population including all randomized participants
To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis. IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment
|
NA Months
Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.
|
16.5 Months
Interval 14.0 to 17.1
|
SECONDARY outcome
Timeframe: From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.Population: Intent-to-treat population including all randomized participants
PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
Progression-free Survival (PFS) Per Investigator Assessment
|
NA Months
Interval 45.8 to
Kaplan-Meier Estimates for median PFS and upper 95% CI were not reached for Arm A.
|
16.8 Months
Interval 14.1 to 22.5
|
SECONDARY outcome
Timeframe: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-upPopulation: Intent-to-treat population including all randomized participants
IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis
|
126 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: Investigator assessments were done from randomization date until date of death or date of exit from study or data cut off date on 03Sep2021, whichever came first, up to 53 months of follow-up.Population: Intent-to-treat population including all randomized participants
IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021
|
128 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.Population: Intent-to treat (ITT) population including all randomized participants
Overall Survival (OS) was based on data cutoff date of 03Sep2021
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Kaplan-Meier estimate for median OS and 95% CIs were not reached.
|
NA Months
Kaplan-Meier estimate for median OS and 95% CIs were not reached.
|
SECONDARY outcome
Timeframe: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-upPopulation: Intent to treat (ITT) population including all randomized participants
Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.
|
NA Months
Kaplan-Meier Estimate of median DOR and 95% CI were not reached.
|
13.6 Months
Interval 11.9 to
Kaplan-Meier estimate of upper 95% CI for median DOR was not reached.
|
SECONDARY outcome
Timeframe: Investigator assessments were done from randomization date until date of death or study discontinuation or data cutoff date on 03Sep2021, whichever came first up to 53 months of follow-up.Population: Intent to treat (ITT) population including all randomized participants
Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff
|
NA Months
Interval 41.5 to
Kaplan-Meier estimate of median DOR and upper 95% CI were not reached.
|
18.3 Months
Interval 11.9 to 21.7
|
SECONDARY outcome
Timeframe: From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.Population: Intent to treat (ITT) population including all randomized participants
Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.
Outcome measures
| Measure |
Arm A: Acalabrutinib Monotherapy
n=155 Participants
Acalabrutinib 100 mg orally twice a day
|
Arm B: Investigators Choice
n=155 Participants
Idelalisib+Rituximab or Bendamustine + Retuximab
|
|---|---|---|
|
Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff
|
NA Months
Interval 46.9 to
Kaplan-Meier estimate of median TTNT and upper 95% CI were not reached.
|
22.5 Months
Interval 17.5 to 25.9
|
Adverse Events
Arm A- Acala. 100 mg BID
Serious events: 70 serious events
Other events: 149 other events
Deaths: 41 deaths
Arm B: Investigator Choice (IR or BR)-Main Study Period
Serious events: 86 serious events
Other events: 145 other events
Deaths: 33 deaths
Arm B Cross Over
Serious events: 31 serious events
Other events: 73 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Arm A- Acala. 100 mg BID
n=154 participants at risk
Arm A- Acalabrutinib 100 mg BID
|
Arm B: Investigator Choice (IR or BR)-Main Study Period
n=153 participants at risk
IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
|
Arm B Cross Over
n=80 participants at risk
Arm B Investigator Choice Crossed Over to Acalabrutinib
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Chest pain
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Chills
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Condition aggravated
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Fatigue
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
General physical health deterioration
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Malaise
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Pyrexia
|
3.2%
5/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.9%
9/153 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Sudden death
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Secondary immunodeficiency
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Appendicitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Brain abscess
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Bronchitis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Bronchitis pneumococcal
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Covid-19
|
1.9%
3/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Covid-19 pneumonia
|
3.9%
6/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Cellulitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Device related infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Diverticulitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Epididymitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Escherichia sepsis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Herpes zoster
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Influenza
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Peritonitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia
|
9.1%
14/154 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
8.5%
13/153 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
8.8%
7/80 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia fungal
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Postoperative wound infection
|
0.65%
1/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Sepsis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Septic shock
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Angina unstable
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
3/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiac arrest
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Transaminases increased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiac failure
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Coronary artery disease
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.9%
3/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Aphasia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Facial paresis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Hemiparesis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal colic
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal impairment
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hypertrophy
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Aortic aneurysm
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Hypertension
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Iliac artery stenosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
12.4%
19/153 • Number of events 22 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
Other adverse events
| Measure |
Arm A- Acala. 100 mg BID
n=154 participants at risk
Arm A- Acalabrutinib 100 mg BID
|
Arm B: Investigator Choice (IR or BR)-Main Study Period
n=153 participants at risk
IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
|
Arm B Cross Over
n=80 participants at risk
Arm B Investigator Choice Crossed Over to Acalabrutinib
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastrointestinal tract mucosal pigmentation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Mouth cyst
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Nausea
|
8.4%
13/154 • Number of events 16 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
15.7%
24/153 • Number of events 27 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.6%
4/154 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.3%
2/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Stomatitis
|
2.6%
4/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.9%
6/153 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Toothache
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
6/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.9%
9/153 • Number of events 9 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
7.5%
6/80 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Asthenia
|
6.5%
10/154 • Number of events 13 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.5%
10/153 • Number of events 13 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
7.5%
6/80 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Chest pain
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Chills
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.5%
10/153 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Device related thrombosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Extravasation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Fatigue
|
12.3%
19/154 • Number of events 21 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
11.8%
18/153 • Number of events 18 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Feeling cold
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Gait disturbance
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
General physical health deterioration
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Hernia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Hyperthermia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Inflammation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Influenza like illness
|
3.2%
5/154 • Number of events 9 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Infusion site extravasation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Malaise
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Mucosal inflammation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Oedema peripheral
|
7.1%
11/154 • Number of events 12 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.2%
8/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Pain
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Peripheral swelling
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Pyrexia
|
16.2%
25/154 • Number of events 33 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
19.0%
29/153 • Number of events 51 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
12.5%
10/80 • Number of events 13 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Secretion discharge
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Swelling face
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Hypersensitivity
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
4.5%
7/154 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Immune system disorders
Secondary immunodeficiency
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Abscess limb
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Atypical pneumonia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Bronchitis
|
12.3%
19/154 • Number of events 30 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
7.8%
12/153 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Bronchitis pneumococcal
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Covid-19
|
6.5%
10/154 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Covid-19 pneumonia
|
3.9%
6/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Cellulitis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Chronic sinusitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Conjunctivitis
|
3.9%
6/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.5%
27/154 • Number of events 52 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
11.1%
17/153 • Number of events 26 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
20.0%
16/80 • Number of events 20 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Diverticulitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Ear infection
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Epididymitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Epstein-barr virus infection reactivation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Erysipelas
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Eye infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Eye infection bacterial
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Folliculitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Furuncle
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Gastroenteritis viral
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Gastrointestinal infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Hepatitis b
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.0%
37/154 • Number of events 75 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
43.8%
67/153 • Number of events 202 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
20.0%
16/80 • Number of events 16 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Hepatitis b reactivation
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Hepatitis c
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Herpes simplex
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Herpes virus infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Herpes zoster
|
3.9%
6/154 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Herpes zoster reactivation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Impetigo
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Infected dermal cyst
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Influenza
|
3.2%
5/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.9%
6/153 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Joint abscess
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Localised infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Nasal herpes
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Nasopharyngitis
|
8.4%
13/154 • Number of events 23 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
9.2%
14/153 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Oral candidiasis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Oral fungal infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Oral herpes
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Otitis externa
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Otitis media
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pharyngitis
|
3.2%
5/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia
|
19.5%
30/154 • Number of events 30 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
12.4%
19/153 • Number of events 19 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
11.2%
9/80 • Number of events 9 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia fungal
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Postoperative wound infection
|
0.65%
1/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
20/154 • Number of events 50 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
15.7%
24/153 • Number of events 53 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
13.8%
11/80 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Respiratory tract infection
|
11.7%
18/154 • Number of events 27 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.2%
8/153 • Number of events 15 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
7.5%
6/80 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.9%
3/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Rhinitis
|
6.5%
10/154 • Number of events 12 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Sinusitis
|
4.5%
7/154 • Number of events 12 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Skin bacterial infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Skin infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Tinea pedis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Tonsillitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Tooth abscess
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Tooth infection
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Tracheobronchitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.1%
31/154 • Number of events 42 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
15.7%
24/153 • Number of events 31 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Urinary tract infection
|
5.2%
8/154 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
4.6%
7/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Viral infection
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Wound infection
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Infections and infestations
Wound infection pseudomonas
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.4%
13/154 • Number of events 23 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Eyelid contusion
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Angina pectoris
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
4/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
11.1%
17/153 • Number of events 29 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.2%
5/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Angina unstable
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Palate injury
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Arrhythmia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Injury, poisoning and procedural complications
Wound
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
4/154 • Number of events 19 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
11.1%
17/153 • Number of events 30 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
11/154 • Number of events 11 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
4/154 • Number of events 23 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
8.5%
13/153 • Number of events 21 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood bilirubin increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood cholesterol increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood creatinine increased
|
3.9%
6/154 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.2%
8/153 • Number of events 9 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood immunoglobulin g decreased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood iron decreased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood potassium decreased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Atrial flutter
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood pressure increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood urea
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood urea increased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Blood uric acid increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Borrelia test positive
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Breath sounds abnormal
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
C-reactive protein increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Candida test positive
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Cardiac murmur
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Bradycardia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Faecal calprotectin increased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Gamma-glutamyltransferase decreased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Hepatitis b dna assay positive
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Human rhinovirus test positive
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Intraocular pressure increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Lymphocyte count decreased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Lymphocyte count increased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Neutrophil count decreased
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.5%
10/153 • Number of events 23 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Platelet count decreased
|
3.2%
5/154 • Number of events 12 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.9%
6/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Sars-cov-2 test positive
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Streptococcus test positive
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Transaminases increased
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.9%
9/153 • Number of events 18 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Weight decreased
|
3.2%
5/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.9%
6/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Investigations
Weight increased
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Carbohydrate intolerance
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.8%
9/154 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.9%
6/153 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Gout
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.2%
5/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.5%
7/154 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.5%
10/153 • Number of events 11 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Metabolism and nutrition disorders
Vitamin k deficiency
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
20/154 • Number of events 24 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.2%
8/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
17.5%
14/80 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
12/154 • Number of events 15 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.9%
9/153 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
2/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.9%
6/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
5/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.9%
6/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
8/154 • Number of events 11 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.3%
2/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
7.1%
11/154 • Number of events 11 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Coronary artery disease
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein barr virus positive mucocutaneous ulcer
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Joint neoplasm
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Palpitations
|
3.2%
5/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
6.5%
10/154 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Ataxia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Cognitive disorder
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Dizziness
|
6.5%
10/154 • Number of events 17 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Dizziness postural
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Dysaesthesia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Dysarthria
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Dysgeusia
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Epilepsy
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Facial paresis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Headache
|
23.4%
36/154 • Number of events 44 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
4.6%
7/153 • Number of events 9 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
15.0%
12/80 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Sinus bradycardia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Hemiparesis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Hypoaesthesia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Memory impairment
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Neuralgia
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Paraesthesia
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Post herpetic neuralgia
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Radiculopathy
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Sciatica
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Somnolence
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Syncope
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Tremor
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Affective disorder
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Agitation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Tachycardia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Anxiety
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Confusional state
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Depression
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Eating disorder
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Insomnia
|
5.8%
9/154 • Number of events 12 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.2%
8/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Irritability
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Sleep disorder
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Psychiatric disorders
Stress
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.65%
1/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Dysuria
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Haematuria
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Polyuria
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal colic
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal cyst
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal failure
|
4.5%
7/154 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal impairment
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Spermatocele
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Vulval oedema
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.5%
27/154 • Number of events 37 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
13.1%
20/153 • Number of events 29 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
10.0%
8/80 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
8/154 • Number of events 11 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.2%
5/154 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
5/154 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haematoma
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
5/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
4/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.9%
6/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Presbyacusis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.6%
4/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.6%
4/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
5/154 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
4.6%
7/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
15/154 • Number of events 18 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
12.4%
19/153 • Number of events 33 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Endocrine disorders
Hypothyroidism
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.9%
3/154 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.65%
1/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
1.9%
3/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.2%
5/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Accommodation disorder
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Arterial haemorrhage
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Capillary fragility
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Cataract
|
2.6%
4/154 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Flushing
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Haematoma
|
6.5%
10/154 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.6%
4/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Haemorrhage
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Hot flush
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Hypertension
|
7.1%
11/154 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
4.6%
7/153 • Number of events 9 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Hypotension
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.8%
3/80 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Conjunctival haemorrhage
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Peripheral venous disease
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Phlebitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Phlebitis superficial
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Poor peripheral circulation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Varicose vein
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Vasculitis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Dry eye
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Eye irritation
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Myopia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Ocular hyperaemia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Orbital myositis
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Vision blurred
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.0%
3/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Eye disorders
Visual acuity reduced
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.65%
1/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
9/154 • Number of events 10 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.2%
8/153 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
6.2%
5/80 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.3%
2/154 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.9%
6/154 • Number of events 8 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 5 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
5.0%
4/80 • Number of events 4 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 7 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
14/154 • Number of events 15 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
9.2%
14/153 • Number of events 14 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Dental caries
|
2.6%
4/154 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
32/154 • Number of events 45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
41.8%
64/153 • Number of events 128 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
12.5%
10/80 • Number of events 12 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
2/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Blood and lymphatic system disorders
Hypergammaglobulinaemia
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Dysbiosis
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
3/154 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
3.3%
5/153 • Number of events 6 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.2%
1/80 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Dysphagia
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
2.5%
2/80 • Number of events 2 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/153 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
1.3%
2/153 • Number of events 3 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Flatulence
|
0.65%
1/154 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/154 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.65%
1/153 • Number of events 1 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
0.00%
0/80 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/Investigator will not publish or publicly present any study results without prior approval or prior to 12 months following completion of the study.
- Publication restrictions are in place
Restriction type: OTHER