Trial Outcomes & Findings for Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) (NCT NCT03742895)
NCT ID: NCT03742895
Last Updated: 2026-08-14
Results Overview
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response was assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with no evidence of disease \[NED\] on bone scan; PR: soft tissue PR with non-progressive disease, non-evaluable \[NE\], or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan). Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by BICR is presented.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
329 participants
Primary outcome timeframe
Up to approximately 78 months
Results posted on
2026-08-14
Participant Flow
Participant milestones
| Measure |
Cohort 1: BRCA1/2 Mutated
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
93
|
141
|
7
|
|
Overall Study
Treated
|
86
|
92
|
141
|
7
|
|
Overall Study
Efficacy Analysis Population
|
86
|
90
|
140
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
88
|
93
|
141
|
7
|
Reasons for withdrawal
| Measure |
Cohort 1: BRCA1/2 Mutated
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Overall Study
Randomized By Mistake Without Study Treatment
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
2
|
0
|
|
Overall Study
Death
|
77
|
84
|
132
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Ongoing
|
6
|
5
|
6
|
3
|
Baseline Characteristics
Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)
Baseline characteristics by cohort
| Measure |
Cohort 1: BRCA1/2 Mutated
n=88 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
n=93 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
n=141 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
n=7 Participants
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 11.0 • n=11 Participants
|
57.9 years
STANDARD_DEVIATION 12.1 • n=11 Participants
|
59.6 years
STANDARD_DEVIATION 12.3 • n=22 Participants
|
53.4 years
STANDARD_DEVIATION 6.9 • n=255 Participants
|
59.4 years
STANDARD_DEVIATION 11.9 • n=83 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=11 Participants
|
70 Participants
n=11 Participants
|
77 Participants
n=22 Participants
|
7 Participants
n=255 Participants
|
188 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=11 Participants
|
23 Participants
n=11 Participants
|
64 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
141 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=11 Participants
|
28 Participants
n=11 Participants
|
30 Participants
n=22 Participants
|
3 Participants
n=255 Participants
|
77 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=11 Participants
|
60 Participants
n=11 Participants
|
104 Participants
n=22 Participants
|
4 Participants
n=255 Participants
|
236 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
7 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
16 Participants
n=83 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
10 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
18 Participants
n=22 Participants
|
3 Participants
n=255 Participants
|
42 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
4 Participants
n=83 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=11 Participants
|
74 Participants
n=11 Participants
|
99 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
229 Participants
n=83 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=11 Participants
|
9 Participants
n=11 Participants
|
14 Participants
n=22 Participants
|
3 Participants
n=255 Participants
|
29 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
6 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
15 Participants
n=83 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The efficacy analysis population includes all participants who received at least 1 dose of study treatment and had data available for this outcome measure.
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response was assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with no evidence of disease \[NED\] on bone scan; PR: soft tissue PR with non-progressive disease, non-evaluable \[NE\], or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan). Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by BICR is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=86 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
n=90 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
n=140 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
n=7 Participants
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Cohorts 1, 2, 3: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1
|
16.3 Percentage of participants
Interval 9.2 to 25.8
|
8.9 Percentage of participants
Interval 3.9 to 16.8
|
8.6 Percentage of participants
Interval 4.5 to 14.5
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The efficacy analysis population includes all participants who had a confirmed complete (CR) or partial response (PR), who received at least 1 dose of study treatment, and had data available for this outcome measure.
For participants with confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR or PR to progressive disease (PD) or death. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also PD. Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks. DOR is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=14 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
n=8 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
n=12 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
n=2 Participants
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Cohorts 1, 2, 3: Duration of Response (DOR) as Assessed by BICR According to Modified RECIST 1.1 or PCWG-Modified RECIST 1.1
|
18.4 Months
Interval 5.1 to
NA= upper limit not reached due to insufficient number of responding participants with relapse.
|
9.7 Months
Interval 3.8 to
NA= upper limit not reached, due to insufficient number of responding participants with relapse.
|
7.3 Months
Interval 5.6 to 18.8
|
NA Months
NA= Median, lower, and upper limits, not reached and limits were not presented at time of data cut-off, due to insufficient number of responding participants with relapse.
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsOS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. OS will be reported for all participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The efficacy analysis population includes all participants who received at least 1 dose of study treatment and had data available for this outcome measure.
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks. The PFS per modified RECIST 1.1/PCWG-modified RECIST 1.1 as assessed by BICR is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=86 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
n=90 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
n=140 Participants
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
n=7 Participants
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Cohorts 1, 2, 3: Progression Free Survival (PFS) as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1
|
3.2 Months
Interval 1.9 to 4.7
|
2.0 Months
Interval 1.9 to 3.4
|
3.3 Months
Interval 1.9 to 3.7
|
4.2 Months
Interval 1.4 to
NA= PFS upper limit not reached at time of data cut-off due to insufficient number of responding participants
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsAn AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 78 monthsAn AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants in Cohort 1 \& 2 who met protocol specified biomarker requirements, were HRRm positive, received ≥1 dose of study treatment, and had data available for this outcome measure. Per protocol, participants had centrally-confirmed known/suspected deleterious mutations in at least 1 of the specified 15 genes involved in HRR based on the Lynparza HRR-HRD Assay. Per protocol, Cohort 1 \& 2 were combined as a pre-specified secondary efficacy analysis population.
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan). Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ. Per protocol, the secondary ORR outcome measure analysis for HRRm positive participants in Cohort 1 (BRCA 1/2) \& Cohort 2 \[(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)\] combined, is presented here. Per protocol, Cohort 1 \& 2 were combined as a pre-specified secondary efficacy analysis population.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=226 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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|---|---|---|---|---|
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Combined Cohort 1+2: ORR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRRm Positive
|
11.5 Percentage of Participants
Interval 7.7 to 16.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants in Cohort 1 \& 2 who met protocol specified biomarker requirements, were HRD+, received ≥1 dose of treatment, and had data available for this outcome measure. Per protocol, participants had tumors that harbor centrally-confirmed known/suspected deleterious mutations in BRCA1/2 or have a LOH score ≥16 based on the Lynparza HRR-HRD Assay. Per protocol, Cohort 1 \& 2 were combined as a pre-specified secondary efficacy analysis population.
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan). Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ. Per protocol, the secondary ORR outcome measure analysis for HRD+ participants in Cohort 1 (BRCA 1/2) and Cohort 2 \[(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)\] combined, is presented here. Per protocol, Cohort 1 and Cohort 2 were combined as a pre-specified secondary efficacy analysis population.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=198 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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|---|---|---|---|---|
|
Combined Cohort 1+2: ORR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 In Participants Who Are HRD Positive (HRD+)
|
14.1 Percentage of Participants
Interval 9.6 to 19.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants in Cohort 1 and 2 regardless of BRCA1/2, HRRm, or HRD+ biomarker status. Per protocol, participants were included in the analysis for this outcome measure if they met protocol specified biomarker requirements for enrollment, received ≥1 dose of study treatment, and had data available for this outcome measure. Per protocol, Cohort 1 and 2 were combined as a pre-specified secondary efficacy analysis population.
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response will be assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with no evidence of disease \[NED\] on bone scan; PR: soft tissue PR with non-progressive disease, non-evaluable \[NE\], or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan). Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ. Per protocol, the secondary ORR outcome measure analysis for all participants regardless of biomarker status in Cohort 1 (BRCA 1/2) and Cohort 2 (\[HRRm, BRCA Non-mutated\]; \[HRD+, HRR Non-mutated\]) combined, is presented here.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=316 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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|---|---|---|---|---|
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Combined Cohort 1+2: ORR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status
|
10.8 Percentage of Participants
Interval 7.6 to 14.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants with confirmed CR/PR in Cohort 1 \& 2 who met protocol specified biomarker requirements, were HRRm positive, received ≥1 dose of study treatment, \& had data available. Per protocol, participants had centrally-confirmed known/suspected deleterious mutations in at least 1 of the specified 15 genes involved in HRR based on the Lynparza HRR-HRD Assay. Per protocol, Cohort 1 \& 2 were combined as pre-specified secondary efficacy analysis population.
For participants with CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR/PR to PD or death. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions \& absolute increase of ≥5 mm or appearance of ≥1 new lesion. Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks. DOR for HRRm positive participants with CR/PR in Cohort 1 \& 2 combined is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=26 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Combined Cohort 1+2: DOR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRRm Positive
|
17.5 Months
Interval 7.0 to 19.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants in Cohort 1 \& 2 who met protocol specified biomarker requirements, were HRD+, received ≥1 dose of treatment, and had data available for this outcome measure. Per protocol, participants had tumors that harbor centrally-confirmed known/suspected deleterious mutations in BRCA1/2 or have a LOH score ≥16 based on the Lynparza HRR-HRD Assay. Per protocol, Cohort 1 \& 2 were combined as a pre-specified secondary efficacy analysis population.
For participants with CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR/PR to PD or death. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions \& absolute increase of ≥5 mm or appearance of ≥1 new lesion. Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks. DOR for HRD+ participants with CR/PR in Cohort 1 \& 2 combined is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=28 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Combined Cohort 1+2: DOR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 In Participants Who Are HRD Positive (HRD+)
|
17.5 Months
Interval 7.5 to 20.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants with confirmed CR/PR in Cohort 1 and 2 regardless of BRCA1/2, HRRm, or HRD+ biomarker status. Per protocol, participants were included in the analysis for this outcome measure if they met protocol specified biomarker requirements for enrollment, received ≥1 dose of study treatment, and had data available for this outcome measure. Per protocol, Cohort 1 and 2 were combined as a pre-specified secondary efficacy analysis population.
For participants with CR (disappearance of all target lesions) or PR (≥30% decrease in sum of diameters of target lesions) as assessed by BICR per modified RECIST; or, for participants with prostate cancer, per PCWG-modified RECIST 1.1 (CR: soft tissue CR with NED on bone scan; PR: soft tissue PR with non-progressive disease, NE, or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan) DOR was defined as time from first documented CR/PR to PD or death. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions \& absolute increase of ≥5 mm or appearance of ≥1 new lesion. Per PCWG, PD was ≥2 new bone lesions (not tumor flare) persisting ≥6 weeks. DOR for all participants in Cohort 1 \& 2 combined with CR/PR is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=34 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Combined Cohort 1+2: DOR as Assessed by BICR Per Modified RECIST 1.1 or PCWG-modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status
|
16.0 Months
Interval 7.0 to 19.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsOS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Per protocol, the secondary OS outcome measure analysis for HRRm positive participants in Cohort 1 (BRCA 1/2) and Cohort 2 \[(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)\] combined, will be presented. Per protocol, Cohort 1 and Cohort 2 will be combined as a pre-specified secondary efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 78 monthsOS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Per protocol, the secondary OS outcome measure analysis for HRD+ participants in Cohort 1 (BRCA 1/2) and Cohort 2 \[(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)\] combined, will be presented. Per protocol, Cohort 1 and Cohort 2 will be combined as a pre-specified secondary efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 78 monthsOS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Per protocol, the secondary OS outcome measure analysis for all participants regardless of biomarker status in Cohort 1 (BRCA 1/2) and Cohort 2 \[(HRRm, BRCA Non-mutated); (HRD+, HRR Non-mutated)\] combined, will be presented. Per protocol, Cohort 1 and Cohort 2 will be combined as a pre-specified secondary efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants in Cohort 1 \& 2 who met protocol specified biomarker requirements, were HRRm positive, received ≥1 dose of study treatment, \& had data available. Per protocol, participants had centrally-confirmed known/suspected deleterious mutations in at least 1 of the specified 15 genes involved in HRR based on the Lynparza HRR-HRD Assay. Per protocol, Cohort 1 \& 2 were combined as a pre-specified secondary efficacy analysis population.
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks. Per protocol, the PFS analysis for HRRm positive participants in Cohort 1 and Cohort 2 combined is presented here.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=226 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Combined Cohort 1+2: PFS as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRRm Positive
|
3.2 Months
Interval 1.9 to 3.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants in Cohort 1 \& 2 who met protocol specified biomarker requirements, were HRD+, received ≥1 dose of treatment, and had data available for this outcome measure. Per protocol, participants had tumors that harbor centrally-confirmed known/suspected deleterious mutations in BRCA1/2 or have a LOH score ≥16 based on the Lynparza HRR-HRD Assay. Per protocol, Cohort 1 \& 2 were combined as a pre-specified secondary efficacy analysis population.
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks. Per protocol, the PFS analysis for HRD+ participants in Cohort 1 and Cohort 2 combined is presented here.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=198 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
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|---|---|---|---|---|
|
Combined Cohort 1+2: PFS as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in Participants Who Are HRD Positive (HRD+)
|
2.7 Months
Interval 1.9 to 3.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population included participants in Cohort 1 and 2 regardless of BRCA1/2, HRRm, or HRD+ biomarker status. Per protocol, participants were included in the analysis for this outcome measure if they met protocol specified biomarker requirements for enrollment, received ≥1 dose of study treatment, and had data available for this outcome measure. Per protocol, Cohort 1 and 2 were combined as a pre-specified secondary efficacy analysis population.
PFS was defined as the time from first dose of study treatment to the first documented PD as assessed by BICR per modified RECIST 1.1 or PCWG-modified RECIST 1.1 (for participants with prostate cancer), or death due to any cause, whichever occurred first. Per protocol, RECIST 1.1 was modified to allow ≤10 target lesions total (up to 5 per organ). Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions and the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per PCWG, PD was ≥2 new bone lesions, confirmed to not represent tumor flare, and persistent for ≥6 weeks. Per protocol, the PFS analysis for all participants regardless of biomarker status in Cohort 1 \& 2 is presented here.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=316 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Combined Cohort 1+2: PFS as Assessed by BICR Per Modified RECIST 1.1 or PCWG-Modified RECIST 1.1 in All Combined Cohort 1+2 Participants Regardless of Biomarker Status
|
2.6 Months
Interval 1.9 to 3.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population includes all participants in Cohort 2 with BRCA1/2 non-mutated ovarian cancer, who received at least 1 dose of study treatment, and had data available for this outcome measure.
Time to earliest progression by CA-125 was defined as the time from first dose to progression based on CA-125. For participants with BRCA1/2 non-mutated ovarian cancer only, progression by CA-125 was defined as either CA-125 ≥2× upper limit normal (ULN) on 2 occasions 1 week apart or, for participants with elevated CA-125 (≥ULN) at baseline, ≥2× the nadir value on 2 occasions 1 week apart. Time to earliest progression based on CA-125 is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=36 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Participants With BRCA1/2 Non-Mutated Ovarian Cancer: Time to Earliest Progression by Cancer Antigen-125 (CA-125)
|
9.2 Months
Interval 5.4 to
NA = Upper limit of 95% CI for Time to PSA Progression cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPopulation: The analysis population includes all participants in Cohort 1 and Cohort 2 with prostate cancer who had baseline PSA measurements, received at least one dose of study treatment, and had data available for this outcome measure.
PSA response was defined as a reduction in PSA level ≥50% from baseline measured twice at least 3 weeks apart. For participants with prostate cancer with baseline PSA measurements available, the PSA response rate as assessed is presented.
Outcome measures
| Measure |
Cohort 1: BRCA1/2 Mutated
n=32 Participants
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Participants With Prostate Cancer: Prostate-Specific Antigen (PSA) Response Rate
|
37.5 Percentage of Participants
Interval 21.1 to 56.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 78 monthsPFS2 was defined as the time from the first dose of study medication to subsequent disease progression on next-line treatment or death due to any cause, whichever occurred first, as assessed by the investigator. PFS2 for participants with sBRCAm breast cancer in Cohort 3 will be reported.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: BRCA1/2 Mutated
Serious events: 25 serious events
Other events: 76 other events
Deaths: 79 deaths
Cohort 2: HRD+, HRR Non-mutated
Serious events: 26 serious events
Other events: 80 other events
Deaths: 86 deaths
Cohort 2: HRRm, BRCA1/2 Non-mutated
Serious events: 44 serious events
Other events: 123 other events
Deaths: 133 deaths
Cohort 3: sBRCAm Breast Cancer
Serious events: 1 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cohort 1: BRCA1/2 Mutated
n=86 participants at risk
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
n=92 participants at risk
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
n=141 participants at risk
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
n=7 participants at risk
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
2/86 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
4/92 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
2/86 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.1%
3/141 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.2%
1/86 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Necrotising oesophagitis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chest pain
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Death
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Biliary obstruction
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Device related infection
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
3.5%
3/86 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
4/92 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
3.5%
5/141 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.1%
3/141 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Cardiac output decreased
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.3%
2/86 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to heart
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Neuralgia
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
2/86 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
2/92 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Peripheral vein thrombosis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
Other adverse events
| Measure |
Cohort 1: BRCA1/2 Mutated
n=86 participants at risk
Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had loss of heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib, 300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRD+, HRR Non-mutated
n=92 participants at risk
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the other protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a loss of heterozygosity (LOH) score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+ (BRCA1/2 nonmutated/ HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 2: HRRm, BRCA1/2 Non-mutated
n=141 participants at risk
Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the other protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
Cohort 3: sBRCAm Breast Cancer
n=7 participants at risk
Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort 3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
39.5%
34/86 • Number of events 39 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
37.0%
34/92 • Number of events 42 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
34.8%
49/141 • Number of events 61 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
42.9%
3/7 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.8%
5/86 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
4/92 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.8%
5/86 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
6/92 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.8%
4/141 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
9/86 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
13.0%
12/92 • Number of events 14 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
12.1%
17/141 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
5/86 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
6/92 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.0%
7/141 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
19.8%
17/86 • Number of events 19 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
13.0%
12/92 • Number of events 13 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
11.3%
16/141 • Number of events 19 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
9/86 • Number of events 12 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
15.2%
14/92 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.2%
20/141 • Number of events 25 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
5/86 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
9.8%
9/92 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.0%
7/141 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
46.5%
40/86 • Number of events 43 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
40.2%
37/92 • Number of events 45 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
41.8%
59/141 • Number of events 78 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
4.7%
4/86 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
4/92 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
8/141 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
23/86 • Number of events 27 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
21.7%
20/92 • Number of events 30 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
20.6%
29/141 • Number of events 36 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
11.6%
10/86 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
23/92 • Number of events 25 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.2%
20/141 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Fatigue
|
26.7%
23/86 • Number of events 28 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
20.7%
19/92 • Number of events 19 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
16.3%
23/141 • Number of events 25 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
7.0%
6/86 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
3.5%
5/141 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
3.5%
3/86 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
6/92 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
3.5%
5/141 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
5.8%
5/86 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
4/92 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
8/141 • Number of events 12 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Rhinitis
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
3/86 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.4%
5/92 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
10/141 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
7/86 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
6/92 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
8/141 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
9/86 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
7.6%
7/92 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.4%
9/141 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
11.6%
10/86 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
4/92 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
12/141 • Number of events 14 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
3.5%
3/86 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
2/92 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.4%
9/141 • Number of events 15 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
5.8%
5/86 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
7.6%
7/92 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
8/141 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Body temperature increased
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
7.0%
6/86 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
2/92 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.8%
4/141 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
7.0%
6/86 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
2/92 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.1%
3/141 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight decreased
|
10.5%
9/86 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
9.8%
9/92 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.0%
7/141 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
8.1%
7/86 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
4/92 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.8%
4/141 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.7%
23/86 • Number of events 29 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
16.3%
15/92 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
19.9%
28/141 • Number of events 29 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
8.7%
8/92 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.4%
9/141 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.5%
3/86 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
8.7%
8/92 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
6/141 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
8/86 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.4%
5/92 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
4.3%
6/141 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
7/86 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
9.8%
9/92 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
7.8%
11/141 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
2/92 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.8%
4/141 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
5/86 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
6/92 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
3.5%
5/141 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
8.1%
7/86 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
9.8%
9/92 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
6.4%
9/141 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
7.0%
6/86 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.4%
5/92 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
3.5%
5/141 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Headache
|
4.7%
4/86 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
9.8%
9/92 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
12/141 • Number of events 12 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
5.8%
5/86 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.1%
3/141 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
4/86 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
13.0%
12/92 • Number of events 13 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
10/141 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
3/86 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
7.6%
7/92 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
8/141 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
1.1%
1/92 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
1/86 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
2/92 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
5/86 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/86 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/92 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/141 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs include participants who received ≥1dose of study treatment and are included in treatment group by treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \&"Disease progression" not related to study treatment are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER