Trial Outcomes & Findings for Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer (NCT NCT02007512)
NCT ID: NCT02007512
Last Updated: 2025-09-02
Results Overview
PFS was defined as the time in months from randomization to the first documentation of progression of disease (PD) or death on study due to any cause, whichever occurred first. PD according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) was defined as greater than or equal to (\>=) 20 percent (%) increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
247 participants
Primary outcome timeframe
From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)
Results posted on
2025-09-02
Participant Flow
A total of 247 participants were enrolled.
This was a phase 2, randomized, double blind, placebo-controlled study.
Participant milestones
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Double Blind Treatment Period
STARTED
|
63
|
60
|
64
|
60
|
|
Double Blind Treatment Period
Treated
|
62
|
60
|
63
|
60
|
|
Double Blind Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Double Blind Treatment Period
NOT COMPLETED
|
63
|
60
|
64
|
60
|
|
Open Label Treatment Period
STARTED
|
25
|
12
|
0
|
0
|
|
Open Label Treatment Period
Treated
|
24
|
11
|
0
|
0
|
|
Open Label Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open Label Treatment Period
NOT COMPLETED
|
25
|
12
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Double Blind Treatment Period
Adverse Event
|
4
|
6
|
2
|
2
|
|
Double Blind Treatment Period
Death
|
1
|
0
|
0
|
0
|
|
Double Blind Treatment Period
Disease progression
|
51
|
50
|
57
|
52
|
|
Double Blind Treatment Period
Withdrawal by Subject
|
3
|
3
|
3
|
3
|
|
Double Blind Treatment Period
Protocol Violation
|
1
|
0
|
0
|
1
|
|
Double Blind Treatment Period
Other
|
2
|
1
|
1
|
2
|
|
Double Blind Treatment Period
Randomized but not treated
|
1
|
0
|
1
|
0
|
|
Open Label Treatment Period
Adverse Event
|
1
|
0
|
0
|
0
|
|
Open Label Treatment Period
Other
|
1
|
1
|
0
|
0
|
|
Open Label Treatment Period
Disease progression
|
23
|
11
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=64 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
151 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)Population: ITT population included all the participants randomly assigned to double-blind study treatment.
PFS was defined as the time in months from randomization to the first documentation of progression of disease (PD) or death on study due to any cause, whichever occurred first. PD according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) was defined as greater than or equal to (\>=) 20 percent (%) increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=64 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS)
|
11.8 months
Interval 7.3 to 15.9
|
5.8 months
Interval 3.5 to 10.9
|
3.6 months
Interval 1.9 to 5.5
|
3.9 months
Interval 2.6 to 5.4
|
PRIMARY outcome
Timeframe: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)Population: Dx+ population: Subset of ITT population, defined prior to the first unblinded analysis as meeting the threshold for diagnostic score based on ribonucleic acid (RNA) sequencing data from tumor tissue. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as \>= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=24 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=26 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=15 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=20 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS)
|
16.5 months
Interval 11.0 to
Upper limit of 95% confidence interval was not reached due to insufficient number of events at the time of data cutoff (23 Sep 2016).
|
4.3 months
Interval 1.9 to 10.9
|
6.0 months
Interval 2.3 to 26.7
|
5.3 months
Interval 1.8 to 6.7
|
SECONDARY outcome
Timeframe: From randomization up to 3 yearsPopulation: ITT population included all the participants randomly assigned to double-blind study treatment.
CBR-24: Percentage of participants with a best response of complete response (CR), partial response (PR), or stable disease (SD) sustained for atleast 24 weeks, as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (less than \[\<\] 10 millimeter \[mm\] short axis). PR: \>=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during study as reference. PD: \>=20% increase (an absolute increase of \>=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=64 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Clinical Benefit Rate-24 (CBR-24)
|
61.9 percentage of participants
Interval 48.8 to 73.9
|
45.3 percentage of participants
Interval 32.8 to 58.3
|
20.0 percentage of participants
Interval 10.8 to 32.3
|
31.7 percentage of participants
Interval 20.3 to 45.0
|
SECONDARY outcome
Timeframe: From randomization until CR or PR, whichever occurred first (up to 3 years)Population: ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants with measurable response.
Best objective response rate: Percentage of participants with measurable disease and with a best response of CR or PR according to RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (\<10 mm short axis). PR: Atleast 30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. Response evaluation was based on investigators' judgment.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=39 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=42 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=42 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=42 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Best Objective Response Rate
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
19.0 percentage of participants
Interval 8.6 to 34.1
|
9.5 percentage of participants
Interval 2.7 to 22.6
|
4.8 percentage of participants
Interval 0.6 to 16.2
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until PD, or last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)Population: ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
Duration of objective response: Time from first documentation of CR or PR, to the first documentation of PD or death due to any cause, whichever occurred first as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (\<10 mm short axis). PR: \>=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: \>=20% increase (an absolute increase of \>=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants with no PD or death (after initial CR or PR) at the analysis date were censored at last tumor assessment date prior to date of new antitumor treatment or data cutoff.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=39 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=42 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=42 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=42 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Duration of Objective Response
|
14.0 months
Interval 5.6 to
Upper limit of 95% confidence interval was not reached due to insufficient number of events at the time of data cutoff (23 Sep 2016).
|
9.1 months
Interval 3.2 to 10.2
|
18.3 months
Interval 3.3 to 23.1
|
4.6 months
Interval 1.9 to 7.4
|
SECONDARY outcome
Timeframe: From randomization until first documentation of CR or PR, or last tumor assessment without PD or death prior to new antitumor treatment initiation, whichever occurred first (up to 3 years)Population: ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
Time to response: Time from randomization to first documentation of CR or PR. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (\<10 mm short axis). PR: \>=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: \>=20% increase (an absolute increase of \>=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who were not known to have had a CR or PR were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=39 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=42 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=42 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=42 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Time to Response
|
12.9 months
Interval 7.3 to
Upper limit of 95% confidence interval was not reached due to insufficient number of events at the time of data cutoff (23 Sep 2016).
|
14.0 months
Interval 7.4 to
Upper limit of 95% confidence interval was not reached due to insufficient number of events at the time of data cutoff (23 Sep 2016).
|
NA months
Interval 3.9 to
Median and upper limit of 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff (23 Sep 2016).
|
NA months
Median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff (23 Sep 2016).
|
SECONDARY outcome
Timeframe: From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years)Population: ITT population included all the participants randomly assigned to double-blind study treatment.
Time to progression was defined as the time from the date of randomization to PD defined by the investigator using RECIST 1.1. PD: \>=20% increase (an absolute increase of \>=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who did not experience disease progression, time to progression was right censored at the date of the last tumor assessment prior to data cutoff or date of new antitumor treatment, whichever occurred first.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=64 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Time to Progression
|
11.8 months
Interval 7.3 to 15.9
|
7.4 months
Interval 3.5 to 13.5
|
3.6 months
Interval 1.9 to 5.6
|
3.9 months
Interval 2.6 to 5.4
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population included all the participants randomly assigned to double-blind study treatment.
PFS at 6 months was defined as the percentage of participants with no event of disease progression at Month 6 landmark, estimated by Kaplan-Meier methods. PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD: \>=20% increase (an absolute increase of \>=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. The analysis of PFS was based on investigator assessment of disease progression.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=64 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) at 6 Months
|
66.7 percentage of participants
Interval 53.2 to 77.0
|
50.0 percentage of participants
Interval 37.1 to 61.6
|
31.5 percentage of participants
Interval 19.7 to 43.9
|
33.3 percentage of participants
Interval 21.6 to 45.5
|
SECONDARY outcome
Timeframe: Predose on Day 29, 57 and 113Population: Pharmacokinetic (PK) population for enzalutamide included all participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for enzalutamide or its active metabolite (N-desmethyl enzalutamide).
Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=114 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Concentration Versus Time Summary of Enzalutamide
Day 29
|
14.2 microgram per milliliter
Standard Deviation 2.97
|
—
|
—
|
—
|
|
Concentration Versus Time Summary of Enzalutamide
Day 57
|
14.2 microgram per milliliter
Standard Deviation 3.21
|
—
|
—
|
—
|
|
Concentration Versus Time Summary of Enzalutamide
Day 113
|
13.2 microgram per milliliter
Standard Deviation 4.51
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169Population: PK population for exemestane was defined as all participants in the safety population who received any amount of exemestane and had at least 1 reportable plasma concentration value for exemestane.
Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=114 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=115 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Concentration Versus Time Summary of Exemestane
Day 57: 6 hour Postdose
|
5890 Picogram per milliliter
Standard Deviation 4880
|
5650 Picogram per milliliter
Standard Deviation 6200
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 29: Predose
|
1010 Picogram per milliliter
Standard Deviation 1600
|
943 Picogram per milliliter
Standard Deviation 939
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 29: 1 hour Postdose
|
17000 Picogram per milliliter
Standard Deviation 16400
|
19200 Picogram per milliliter
Standard Deviation 17800
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 29: 6 hour Postdose
|
5590 Picogram per milliliter
Standard Deviation 4750
|
6850 Picogram per milliliter
Standard Deviation 9090
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 57: Predose
|
1160 Picogram per milliliter
Standard Deviation 2590
|
1100 Picogram per milliliter
Standard Deviation 2650
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 57: 1 hour Postdose
|
19900 Picogram per milliliter
Standard Deviation 18600
|
15300 Picogram per milliliter
Standard Deviation 14500
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 113: Predose
|
1160 Picogram per milliliter
Standard Deviation 2870
|
1330 Picogram per milliliter
Standard Deviation 3380
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 113: 1 hour Postdose
|
20800 Picogram per milliliter
Standard Deviation 18100
|
19400 Picogram per milliliter
Standard Deviation 18500
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 113: 6 hour Postdose
|
3510 Picogram per milliliter
Standard Deviation 3850
|
5600 Picogram per milliliter
Standard Deviation 5290
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 169: 1 hour Postdose
|
—
|
22800 Picogram per milliliter
Standard Deviation NA
Standard deviation could not be estimated since only 1 participant was analyzed.
|
—
|
—
|
|
Concentration Versus Time Summary of Exemestane
Day 169: 6 hour Postdose
|
—
|
6020 Picogram per milliliter
Standard Deviation NA
Standard deviation could not be estimated since only 1 participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 29, 57 and 113Population: PK population for N-desmethyl enzalutamide included all the participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for N-desmethyl enzalutamide.
N-desmethyl enzalutamide was the active metabolite of enzalutamide. Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=114 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Concentration Versus Time Summary of N-desmethyl Enzalutamide
Day 29
|
11.6 microgram per milliliter
Standard Deviation 4.10
|
—
|
—
|
—
|
|
Concentration Versus Time Summary of N-desmethyl Enzalutamide
Day 57
|
15.2 microgram per milliliter
Standard Deviation 4.76
|
—
|
—
|
—
|
|
Concentration Versus Time Summary of N-desmethyl Enzalutamide
Day 113
|
15.2 microgram per milliliter
Standard Deviation 5.81
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133Population: ITT population included all the participants randomly assigned to double-blind study treatment. Here, "Overall Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for the specified rows and value as "0" indicated no participants filled the questionnaire for the specified reporting group at specified timepoint.
The EORTC QLQ-C30 questionnaire was a standardized instrument developed to assess the quality of life of people with cancer. Participants self-rated their self-care, activity level, pain/discomfort, and mental health during the past week by choosing 1 of 4 possible responses that recorded the level of intensity (not at all, a little, quite a bit, and very much) within each dimension, where higher score=more level of intensity. The questionnaire also asked the participants to rate their overall health or quality of life within the past week on a scale of 1 to 7, where 1 is "very poor" and 7 is "excellent". Higher global health or quality of life scores indicated better overall health or quality of life. In this outcome measure, global health/quality of life scores are presented.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 5
|
1.2 Units on a scale
Standard Deviation 19.14
|
1.3 Units on a scale
Standard Deviation 21.19
|
-4.6 Units on a scale
Standard Deviation 16.55
|
0.3 Units on a scale
Standard Deviation 15.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 9
|
-1.9 Units on a scale
Standard Deviation 21.21
|
1.3 Units on a scale
Standard Deviation 18.77
|
-5.6 Units on a scale
Standard Deviation 19.13
|
-1.3 Units on a scale
Standard Deviation 14.37
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 17
|
-3.0 Units on a scale
Standard Deviation 19.46
|
-1.8 Units on a scale
Standard Deviation 19.29
|
-7.3 Units on a scale
Standard Deviation 24.45
|
-0.8 Units on a scale
Standard Deviation 15.98
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 25
|
3.6 Units on a scale
Standard Deviation 18.17
|
-3.4 Units on a scale
Standard Deviation 21.03
|
0.6 Units on a scale
Standard Deviation 18.76
|
-4.8 Units on a scale
Standard Deviation 16.79
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 33
|
2.2 Units on a scale
Standard Deviation 19.60
|
-0.9 Units on a scale
Standard Deviation 19.59
|
-8.3 Units on a scale
Standard Deviation 17.68
|
-5.0 Units on a scale
Standard Deviation 15.04
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 41
|
-0.9 Units on a scale
Standard Deviation 16.11
|
-1.5 Units on a scale
Standard Deviation 16.99
|
-9.3 Units on a scale
Standard Deviation 17.40
|
-1.4 Units on a scale
Standard Deviation 9.95
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 49
|
-0.7 Units on a scale
Standard Deviation 19.53
|
0.8 Units on a scale
Standard Deviation 13.67
|
-8.3 Units on a scale
Standard Deviation 12.73
|
-4.2 Units on a scale
Standard Deviation 16.06
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 61
|
3.8 Units on a scale
Standard Deviation 18.32
|
-5.7 Units on a scale
Standard Deviation 19.26
|
-1.2 Units on a scale
Standard Deviation 20.65
|
6.3 Units on a scale
Standard Deviation 18.48
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 73
|
-1.1 Units on a scale
Standard Deviation 19.64
|
0.0 Units on a scale
Standard Deviation 14.03
|
-6.0 Units on a scale
Standard Deviation 15.00
|
2.1 Units on a scale
Standard Deviation 21.92
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 85
|
0.9 Units on a scale
Standard Deviation 27.78
|
-5.2 Units on a scale
Standard Deviation 7.63
|
-3.3 Units on a scale
Standard Deviation 18.26
|
0.0 Units on a scale
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 97
|
-8.3 Units on a scale
Standard Deviation 6.80
|
-2.8 Units on a scale
Standard Deviation 6.80
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 109
|
-13.9 Units on a scale
Standard Deviation 17.35
|
0.0 Units on a scale
|
12.5 Units on a scale
Standard Deviation 5.89
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 121
|
—
|
-8.3 Units on a scale
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life
Week 133
|
—
|
0.0 Units on a scale
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133Population: ITT population included all the participants randomly assigned to double-blind study treatment. Here, "Overall Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for the specified rows and value as "0" indicated no participants filled the questionnaire for the specified reporting group at specified timepoint.
EORTC QLQ-BR23 was disease-specific module for breast cancer developed as supplement for EORTC QLQ-C30 that assessed quality of life of participants with breast cancer.Participants self-rated on frequent symptoms or problems reported by participants with breast cancer,e.g., pain/discomfort, body satisfaction, and self-esteem during past week by choosing 1 of 4 possible responses that recorded level of intensity (not at all, a little, quite a bit, and very much) within each dimension.Raw scores were then transformed to 0-100 scale for analysis and interpretation, where higher scores=more level of intensity, as per EORTC guidelines.Participants also self-rated on sexual health/interest during last 4 weeks using same scale. In this outcome measure body image functioning, sexual functioning, systemic therapy side effects, upset by hair loss parameters were assessed by EORTC QLQ-BR23 questionnaire,total score for each parameter ranged from 0-100,where higher scores=more level of intensity.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 85
|
10.7 units on a scale
Standard Deviation 12.58
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2.4 units on a scale
Standard Deviation 8.82
|
9.5 units on a scale
Standard Deviation 6.73
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4.8 units on a scale
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 97
|
8.2 units on a scale
Standard Deviation 13.52
|
3.2 units on a scale
Standard Deviation 10.29
|
7.1 units on a scale
Standard Deviation 10.10
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—
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 109
|
14.1 units on a scale
Standard Deviation 9.71
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4.8 units on a scale
|
9.5 units on a scale
Standard Deviation 6.73
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—
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 121
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—
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9.5 units on a scale
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—
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—
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 133
|
—
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4.8 units on a scale
|
—
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—
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 5
|
-5.6 units on a scale
Standard Deviation 19.25
|
18.2 units on a scale
Standard Deviation 31.14
|
0.0 units on a scale
Standard Deviation 28.01
|
0.0 units on a scale
Standard Deviation 24.62
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 9
|
0.0 units on a scale
Standard Deviation 36.51
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23.3 units on a scale
Standard Deviation 31.62
|
-6.7 units on a scale
Standard Deviation 18.69
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3.3 units on a scale
Standard Deviation 24.60
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 17
|
0.0 units on a scale
Standard Deviation 21.08
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9.5 units on a scale
Standard Deviation 16.27
|
3.7 units on a scale
Standard Deviation 20.03
|
0.0 units on a scale
Standard Deviation 36.51
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 25
|
-6.7 units on a scale
Standard Deviation 14.91
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28.6 units on a scale
Standard Deviation 35.63
|
26.7 units on a scale
Standard Deviation 27.89
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-8.3 units on a scale
Standard Deviation 16.67
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 33
|
0.0 units on a scale
Standard Deviation 23.57
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-6.7 units on a scale
Standard Deviation 14.91
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20.0 units on a scale
Standard Deviation 29.81
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0.0 units on a scale
Standard Deviation 0.00
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 41
|
-16.7 units on a scale
Standard Deviation 33.33
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0.00 units on a scale
Standard Deviation 0.00
|
13.3 units on a scale
Standard Deviation 18.26
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16.7 units on a scale
Standard Deviation 23.57
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 49
|
6.7 units on a scale
Standard Deviation 36.51
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0.0 units on a scale
Standard Deviation 0.0
|
11.1 units on a scale
Standard Deviation 19.25
|
0.0 units on a scale
Standard Deviation 0.0
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 61
|
11.1 units on a scale
Standard Deviation 19.25
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16.7 units on a scale
Standard Deviation 23.57
|
25.0 units on a scale
Standard Deviation 31.91
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—
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 73
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
|
40.0 units on a scale
Standard Deviation 43.46
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 85
|
33.3 units on a scale
|
—
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 97
|
—
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—
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0.0 units on a scale
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Upset by Hair Loss: Week 109
|
—
|
—
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 5
|
1.8 units on a scale
Standard Deviation 16.01
|
1.9 units on a scale
Standard Deviation 19.10
|
-6.1 units on a scale
Standard Deviation 13.92
|
2.2 units on a scale
Standard Deviation 15.74
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 9
|
-3.5 units on a scale
Standard Deviation 12.91
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-0.2 units on a scale
Standard Deviation 17.91
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-3.7 units on a scale
Standard Deviation 12.51
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2.1 units on a scale
Standard Deviation 15.58
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 17
|
-2.9 units on a scale
Standard Deviation 20.16
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-3.5 units on a scale
Standard Deviation 19.24
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-9.0 units on a scale
Standard Deviation 19.34
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1.3 units on a scale
Standard Deviation 13.98
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 25
|
2.8 units on a scale
Standard Deviation 16.55
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-7.4 units on a scale
Standard Deviation 24.24
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-9.4 units on a scale
Standard Deviation 16.33
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-0.8 units on a scale
Standard Deviation 7.86
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 33
|
-2.9 units on a scale
Standard Deviation 22.08
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-5.7 units on a scale
Standard Deviation 17.55
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-1.9 units on a scale
Standard Deviation 9.11
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-1.8 units on a scale
Standard Deviation 8.12
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 41
|
-2.5 units on a scale
Standard Deviation 18.76
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-1.3 units on a scale
Standard Deviation 13.36
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0.0 units on a scale
Standard Deviation 4.17
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4.2 units on a scale
Standard Deviation 14.43
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 49
|
-2.4 units on a scale
Standard Deviation 19.79
|
-5.2 units on a scale
Standard Deviation 17.57
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-1.2 units on a scale
Standard Deviation 3.15
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1.0 units on a scale
Standard Deviation 8.26
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 61
|
3.3 units on a scale
Standard Deviation 19.94
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-5.7 units on a scale
Standard Deviation 15.23
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-4.8 units on a scale
Standard Deviation 6.56
|
0.0 units on a scale
Standard Deviation 13.61
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 73
|
-3.2 units on a scale
Standard Deviation 29.70
|
-3.2 units on a scale
Standard Deviation 12.05
|
1.2 units on a scale
Standard Deviation 5.75
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4.2 units on a scale
Standard Deviation 10.76
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 85
|
8.3 units on a scale
Standard Deviation 28.05
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-13.5 units on a scale
Standard Deviation 24.78
|
1.7 units on a scale
Standard Deviation 3.73
|
-16.7 units on a scale
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 97
|
-5.6 units on a scale
Standard Deviation 17.35
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-1.4 units on a scale
Standard Deviation 3.40
|
-4.2 units on a scale
Standard Deviation 5.89
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—
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 109
|
0.0 units on a scale
Standard Deviation 35.36
|
0.0 units on a scale
|
-8.3 units on a scale
Standard Deviation 11.79
|
—
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 121
|
—
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0.0 units on a scale
|
—
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Body Image Functioning: Week 133
|
—
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0.0 units on a scale
|
—
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 5
|
1.9 units on a scale
Standard Deviation 12.08
|
-0.3 units on a scale
Standard Deviation 13.40
|
0.3 units on a scale
Standard Deviation 17.00
|
1.9 units on a scale
Standard Deviation 10.16
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 9
|
2.3 units on a scale
Standard Deviation 16.15
|
-1.4 units on a scale
Standard Deviation 16.78
|
1.3 units on a scale
Standard Deviation 15.68
|
2.8 units on a scale
Standard Deviation 11.73
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 17
|
3.3 units on a scale
Standard Deviation 15.65
|
0.0 units on a scale
Standard Deviation 20.21
|
7.2 units on a scale
Standard Deviation 23.48
|
0.6 units on a scale
Standard Deviation 12.18
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 25
|
1.4 units on a scale
Standard Deviation 17.33
|
0.5 units on a scale
Standard Deviation 19.16
|
0.0 units on a scale
Standard Deviation 25.20
|
1.8 units on a scale
Standard Deviation 10.96
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 33
|
4.0 units on a scale
Standard Deviation 20.43
|
3.0 units on a scale
Standard Deviation 12.05
|
7.4 units on a scale
Standard Deviation 22.22
|
4.2 units on a scale
Standard Deviation 12.56
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 41
|
2.4 units on a scale
Standard Deviation 23.00
|
0.8 units on a scale
Standard Deviation 15.34
|
9.3 units on a scale
Standard Deviation 22.22
|
1.7 units on a scale
Standard Deviation 9.46
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 49
|
7.1 units on a scale
Standard Deviation 21.69
|
5.8 units on a scale
Standard Deviation 11.18
|
9.5 units on a scale
Standard Deviation 26.97
|
0.0 units on a scale
Standard Deviation 0.0
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 61
|
7.4 units on a scale
Standard Deviation 21.56
|
1.9 units on a scale
Standard Deviation 20.52
|
7.1 units on a scale
Standard Deviation 25.20
|
0.0 units on a scale
Standard Deviation 13.61
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 73
|
8.3 units on a scale
Standard Deviation 16.98
|
2.8 units on a scale
Standard Deviation 13.91
|
9.5 units on a scale
Standard Deviation 31.71
|
4.2 units on a scale
Standard Deviation 8.33
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 85
|
7.4 units on a scale
Standard Deviation 22.22
|
4.8 units on a scale
Standard Deviation 15.85
|
-6.7 units on a scale
Standard Deviation 27.89
|
0.0 units on a scale
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 97
|
-5.6 units on a scale
Standard Deviation 25.46
|
6.7 units on a scale
Standard Deviation 9.13
|
16.7 units on a scale
Standard Deviation 23.57
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 109
|
0.0 units on a scale
Standard Deviation 16.67
|
0.0 units on a scale
|
33.3 units on a scale
Standard Deviation 0.00
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 121
|
—
|
0.0 units on a scale
|
—
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Sexual Functioning: Week 133
|
—
|
0.0 units on a scale
|
—
|
—
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 5
|
4.5 units on a scale
Standard Deviation 10.59
|
3.7 units on a scale
Standard Deviation 10.06
|
7.1 units on a scale
Standard Deviation 11.49
|
3.3 units on a scale
Standard Deviation 10.82
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 9
|
7.5 units on a scale
Standard Deviation 15.24
|
2.7 units on a scale
Standard Deviation 10.24
|
6.5 units on a scale
Standard Deviation 11.32
|
3.9 units on a scale
Standard Deviation 10.77
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 17
|
7.5 units on a scale
Standard Deviation 10.81
|
2.0 units on a scale
Standard Deviation 8.79
|
7.6 units on a scale
Standard Deviation 16.61
|
6.0 units on a scale
Standard Deviation 12.51
|
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 25
|
8.3 units on a scale
Standard Deviation 13.90
|
2.3 units on a scale
Standard Deviation 7.35
|
5.6 units on a scale
Standard Deviation 10.86
|
5.7 units on a scale
Standard Deviation 16.05
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 33
|
6.5 units on a scale
Standard Deviation 13.54
|
-0.2 units on a scale
Standard Deviation 9.74
|
8.5 units on a scale
Standard Deviation 7.05
|
5.3 units on a scale
Standard Deviation 13.10
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 41
|
8.4 units on a scale
Standard Deviation 10.03
|
1.3 units on a scale
Standard Deviation 9.20
|
10.6 units on a scale
Standard Deviation 4.63
|
2.0 units on a scale
Standard Deviation 10.04
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 49
|
7.8 units on a scale
Standard Deviation 10.18
|
2.5 units on a scale
Standard Deviation 11.03
|
9.7 units on a scale
Standard Deviation 12.78
|
7.7 units on a scale
Standard Deviation 9.84
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 61
|
7.6 units on a scale
Standard Deviation 11.07
|
2.5 units on a scale
Standard Deviation 10.45
|
14.7 units on a scale
Standard Deviation 10.11
|
4.8 units on a scale
Standard Deviation 6.73
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133
Systemic Therapy Side Effects Symptoms: Week 73
|
4.9 units on a scale
Standard Deviation 11.90
|
4.4 units on a scale
Standard Deviation 6.29
|
11.6 units on a scale
Standard Deviation 10.95
|
-1.2 units on a scale
Standard Deviation 5.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, 29, 57, 113 and 169Population: Protocol of this study was amended and data for this outcome measure was not analyzed as per planned analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years)Population: Safety population included all the participants who received study drug either in double blind or in open label treatment period.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
59 Participants
|
58 Participants
|
58 Participants
|
53 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
14 Participants
|
13 Participants
|
10 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years)Population: Safety population included all the participants who received study drug either in double blind or in open label treatment period.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only the participants with treatment-emergent AEs of grade 3 (severe) or higher grade were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity
|
21 Participants
|
16 Participants
|
22 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years)Population: Safety population included all the participants who received study drug either in double blind or in open label treatment period.
Criteria for clinically significant vital sign abnormalities: Systolic blood pressure (SBP): absolute SBP \<90 millimeters of mercury (mmHg) and decrease from baseline (DFB) \>30 mmHg, absolute SBP\>180 mmHg and increase from baseline (IFB) \>40 mmHg, final visit or 2 consecutive visits SBP \>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP \>=140 mmHg, most extreme post-baseline SBP \>=180 mmHg, most extreme SBP \>=140 mmHg and \>=20 mmHg CFB, most extreme SBP \>=180 mmHg and \>=20 mmHg CFB; diastolic blood pressure (DBP): absolute DBP \> 105 mmHg and IFB \>30 mmHg, absolute DBP \<50 mmHg and DFB \>20 mmHg, final visit or 2 consecutive visits DBP \>=15 mmHg CFB, most extreme post-baseline DBP \>=90 mmHg, most extreme post-baseline DBP \>=105 mmHg, most extreme DBP \>=90 mmHg and \>=15 mmHg CFB, most extreme DBP \>=105 mmHg and \>=15 mmHg CFB; heart rate \<50 beats per minute (BPM) and DFB \>20 BPM or heart rate \>120 BPM and IFB \>30 BPM.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities
Blood pressure
|
38 Participants
|
39 Participants
|
43 Participants
|
25 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities
Heart rate
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)Population: Safety population included all the participants who received study drug either in double blind or in open label treatment period.
Laboratory tests included hematology (hematocrit, hemoglobin, platelet count, red blood cell count, total neutrophils \[absolute\] and white blood cell count with differential) and serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase \[ALT\], aspartate transaminase \[AST\], blood urea nitrogen and creatinine, calcium, sodium, potassium, chloride, glucose (non-fasting), lactate dehydrogenase, magnesium, phosphorus/phosphate, total bilirubin, total bicarbonate, total protein and uric acid). Clinically significant abnormality evaluation was based on clinical investigator's judgment.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)Population: Analysis was performed on all randomized participants. Randomization to cohort was based on participant's exposure to advance setting hormonal therapy. Initial randomization was done by IWRS. Later, upon detailed data entry in EDC, it was determined 1 participant was incorrectly assigned to Cht1:Enz+Exe by IWRS,hence counted in Cht2:Enz+Exe by EDC.
PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1 was defined \>=20 % increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. Cht 1: Enz + Exe = Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg; Cht 2: Enz + Exe= Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=64 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=61 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS): By Electronic Data Capture (EDC)
|
11.8 Months
Interval 7.3 to 14.6
|
5.8 Months
Interval 3.5 to 10.9
|
3.6 Months
Interval 1.9 to 5.6
|
3.9 Months
Interval 2.6 to 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)Population: Dx+ population: Subset of ITT population, defined prior to the first unblinded analysis as meeting the threshold for diagnostic score based on ribonucleic acid (RNA) sequencing data from tumor tissue. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as \>= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.
Outcome measures
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=23 Participants
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=26 Participants
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=16 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=20 Participants
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Electronic Data Capture (EDC)
|
16.9 Months
Interval 11.0 to
Upper limit of 95% confidence interval was not reached due to insufficient number of events at the time of data cutoff (23 Sep 2016).
|
4.3 Months
Interval 1.9 to 10.9
|
6.0 Months
Interval 3.5 to 16.6
|
5.3 Months
Interval 1.8 to 6.7
|
Adverse Events
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
Serious events: 14 serious events
Other events: 59 other events
Deaths: 2 deaths
Cohort 1: Placebo + Exemestane 25 mg
Serious events: 13 serious events
Other events: 57 other events
Deaths: 8 deaths
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
Serious events: 10 serious events
Other events: 57 other events
Deaths: 3 deaths
Cohort 2: Placebo + Exemestane 25 mg
Serious events: 8 serious events
Other events: 52 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 participants at risk
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 participants at risk
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 participants at risk
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 participants at risk
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
VOMITING
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
ASTHENIA
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
CHILLS
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
FACIAL PAIN
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
FATIGUE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
PAIN
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Hepatobiliary disorders
HEPATIC HAEMORRHAGE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
BREAST CELLULITIS
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
PNEUMONIA
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Injury, poisoning and procedural complications
OPTIC NERVE INJURY
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Injury, poisoning and procedural complications
RADIATION PNEUMONITIS
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMORRHAGE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
3.2%
2/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
MASTICATION DISORDER
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA PANCREAS
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CONTRALATERAL BREAST CANCER
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHANGIOSIS CARCINOMATOSA
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT ASCITES
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PLASMA CELL MYELOMA
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
BRACHIAL PLEXOPATHY
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
DIZZINESS
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
INTRACRANIAL HAEMATOMA
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
SPEECH DISORDER
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
SYNCOPE
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
Other adverse events
| Measure |
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg
n=62 participants at risk
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 1: Placebo + Exemestane 25 mg
n=63 participants at risk
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
n=60 participants at risk
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
Cohort 2: Placebo + Exemestane 25 mg
n=60 participants at risk
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
10.0%
6/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
5.0%
3/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
CONSTIPATION
|
17.7%
11/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
11.1%
7/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
13.3%
8/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
13.3%
8/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
DIARRHOEA
|
22.6%
14/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
15.9%
10/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
11.7%
7/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
18.3%
11/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
9.5%
6/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
8.3%
5/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
NAUSEA
|
38.7%
24/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
15.9%
10/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
30.0%
18/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
18.3%
11/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
VOMITING
|
17.7%
11/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
11.1%
7/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
10.0%
6/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
5.0%
3/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
ASTHENIA
|
14.5%
9/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
11.1%
7/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
10.0%
6/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
General disorders
FATIGUE
|
38.7%
24/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
36.5%
23/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
35.0%
21/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
21.7%
13/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.2%
2/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
4.8%
3/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
4.8%
3/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
5.0%
3/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
9.7%
6/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
9.5%
6/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
10.0%
6/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
24.2%
15/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
17.5%
11/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
16.7%
10/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
11.7%
7/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
17.7%
11/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
9.5%
6/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
18.3%
11/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
4.8%
3/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
8.3%
5/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
11.3%
7/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
5.0%
3/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
5.0%
3/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
11.3%
7/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
12.7%
8/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
5.0%
3/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
8.3%
5/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
DIZZINESS
|
11.3%
7/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
8.3%
5/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
HEADACHE
|
14.5%
9/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
9.5%
6/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
15.0%
9/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
16.7%
10/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Psychiatric disorders
ANXIETY
|
9.7%
6/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Psychiatric disorders
INSOMNIA
|
8.1%
5/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
8.3%
5/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.1%
10/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
12.7%
8/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
14.5%
9/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
12.7%
8/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
8.3%
5/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
12.9%
8/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
8.3%
5/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Vascular disorders
HOT FLUSH
|
30.6%
19/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
22.2%
14/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
23.3%
14/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
15.0%
9/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Vascular disorders
HYPERTENSION
|
12.9%
8/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
4.8%
3/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.6%
1/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
5.0%
3/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Infections and infestations
INFLUENZA
|
4.8%
3/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.3%
4/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
PARAESTHESIA
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.2%
2/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
4.8%
3/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Nervous system disorders
AMNESIA
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.5%
4/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.2%
2/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
1.7%
1/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
0.00%
0/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.8%
3/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.2%
2/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.6%
1/62 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.2%
2/63 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
3.3%
2/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
6.7%
4/60 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER