Trial Outcomes & Findings for A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (NCT NCT02975934)
NCT ID: NCT02975934
Last Updated: 2025-07-25
Results Overview
The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Results posted on
2025-07-25
Participant Flow
Participant milestones
| Measure |
Rucaparib
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
Rucaparib (Cross-Over Phase)
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase.
After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
|
|---|---|---|---|
|
Treatment Phase
STARTED
|
270
|
135
|
0
|
|
Treatment Phase
Received at Least 1 Dose of Study Drug
|
270
|
130
|
0
|
|
Treatment Phase
Safety Population
|
270
|
130
|
0
|
|
Treatment Phase
COMPLETED
|
270
|
130
|
0
|
|
Treatment Phase
NOT COMPLETED
|
0
|
5
|
0
|
|
Cross-Over Phase
STARTED
|
0
|
0
|
70
|
|
Cross-Over Phase
Received at Least 1 Dose of Study Drug
|
0
|
0
|
70
|
|
Cross-Over Phase
Safety Population
|
0
|
0
|
70
|
|
Cross-Over Phase
COMPLETED
|
0
|
0
|
70
|
|
Cross-Over Phase
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Rucaparib
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
Rucaparib (Cross-Over Phase)
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase.
After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
|
|---|---|---|---|
|
Treatment Phase
Never initiated study drug
|
0
|
5
|
0
|
Baseline Characteristics
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Baseline characteristics by cohort
| Measure |
Rucaparib
n=270 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=135 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
186 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
n=5 Participants
|
71 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
270 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
405 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
216 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
199 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
53 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
111 participants
n=5 Participants
|
56 participants
n=7 Participants
|
167 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
141 participants
n=5 Participants
|
73 participants
n=7 Participants
|
214 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
ECOG Performance Status (at stratification)
0
|
132 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
ECOG Performance Status (at stratification)
1
|
138 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Gene Alteration (at stratification)
BRCA1
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Gene Alteration (at stratification)
BRCA2
|
172 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Gene Alteration (at stratification)
ATM
|
69 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Baseline prostate specific antigen (PSA)
|
26.9 ng/ml
n=5 Participants
|
28.8 ng/ml
n=7 Participants
|
27.8 ng/ml
n=5 Participants
|
|
Gleason score ≥8 at diagnosis
|
173 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Measurable Disease per Independent Radiological Review (IRR)
|
106 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Metastases site(s) by IRR
Bone
|
235 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Metastases site(s) by IRR
Nodal
|
118 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Metastases site(s) by IRR
Visceral
|
74 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Prior Therapies for CRPC
0
|
48 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Prior Therapies for CRPC
≥1
|
222 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Prior therapy (2nd generation androgen receptor pathway inhibitor (ARPI) or docetaxel only)
Abiraterone acetate
|
150 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Prior therapy (2nd generation androgen receptor pathway inhibitor (ARPI) or docetaxel only)
Apalutamide
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Prior therapy (2nd generation androgen receptor pathway inhibitor (ARPI) or docetaxel only)
Enzalutamide
|
119 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Prior therapy (2nd generation androgen receptor pathway inhibitor (ARPI) or docetaxel only)
Docetaxel for hormone-sensitive prostate cancer
|
63 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)Population: ITT Population with BRCA mutated mCRPC.
The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
Outcome measures
| Measure |
Rucaparib
n=201 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=101 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
|
11.2 months
Interval 9.2 to 13.8
|
6.4 months
Interval 5.4 to 8.3
|
PRIMARY outcome
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)Population: ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).
The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
Outcome measures
| Measure |
Rucaparib
n=270 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=135 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
|
10.2 months
Interval 8.3 to 11.2
|
6.4 months
Interval 5.6 to 8.2
|
SECONDARY outcome
Timeframe: From enrollment to completion of study (up to approximately 7 years)Population: ITT Population with BRCA mutated mCRPC.
Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive.
Outcome measures
| Measure |
Rucaparib
n=201 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=101 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Overall Survival in Participants With a BRCA Alteration
|
23.2 months
Interval 19.1 to 25.2
|
21.2 months
Interval 18.0 to 23.1
|
SECONDARY outcome
Timeframe: From enrollment to completion of study (up to approximately 7 years)Population: ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).
Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive.
Outcome measures
| Measure |
Rucaparib
n=270 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=135 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Overall Survival in Participants With a BRCA or ATM Alteration Combined
|
22.8 months
Interval 19.0 to 24.2
|
21.7 months
Interval 18.9 to 23.3
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)Population: ITT Population with BRCA mutated mCRPC and measurable disease at baseline.
ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Rucaparib
n=82 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=41 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
|
37 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)Population: ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC) with measurable disease at baseline.
ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Rucaparib
n=106 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=55 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
|
37 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)Population: ITT Population with BRCA mutated mCRPC and measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response.
DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.
Outcome measures
| Measure |
Rucaparib
n=37 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=7 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
|
7.4 months
Interval 6.4 to 12.7
|
7.4 months
Interval 3.5 to
The upper limit of the confidence interval is inestimable likely due to the small number of participants in this treatment group.
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)Population: ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC) with measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response.
DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.
Outcome measures
| Measure |
Rucaparib
n=37 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=9 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
|
7.4 months
Interval 6.4 to 12.7
|
7.4 months
Interval 3.5 to 14.5
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)Population: ITT Population with BRCA mutated mCRPC.
Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.
Outcome measures
| Measure |
Rucaparib
n=201 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=101 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
PSA Response in Participants With a BRCA Alteration
|
54.7 percentage of participants
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)Population: ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).
Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.
Outcome measures
| Measure |
Rucaparib
n=270 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=135 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
PSA Response in Participants With a BRCA or ATM Alteration Combined
|
41.9 percentage of participants
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 monthsPopulation: The Safety Population included all participants with BRCA mutated mCRPC who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff.
Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria.
Outcome measures
| Measure |
Rucaparib
n=200 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=97 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
|
63.0 percentage of participants
|
22.7 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 monthsPopulation: The Safety Population included all participants who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff.
Defined as the percentage of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD), according to Modified RECIST Version 1.1 with no progression in bone per PCWG3 Criteria.
Outcome measures
| Measure |
Rucaparib
n=269 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=130 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
|
57.6 percentage of participants
|
25.4 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)Population: ITT Population with BRCA mutated mCRPC.
Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
Outcome measures
| Measure |
Rucaparib
n=201 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=101 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
|
6.6 months
Interval 5.9 to 7.7
|
3.8 months
Interval 3.1 to 4.5
|
SECONDARY outcome
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)Population: ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC).
Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
Outcome measures
| Measure |
Rucaparib
n=270 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=135 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
|
5.7 months
Interval 4.6 to 6.5
|
3.6 months
Interval 3.2 to 4.5
|
SECONDARY outcome
Timeframe: From enrollment to up to approximately 25 weeksPopulation: ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
Outcome measures
| Measure |
Rucaparib
n=136 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=35 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
|
-0.8 units on a scale
Standard Error 1.13
|
-3.9 units on a scale
Standard Error 2.23
|
SECONDARY outcome
Timeframe: From enrollment to up to approximately 25 weeksPopulation: ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
Outcome measures
| Measure |
Rucaparib
n=133 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=32 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
BPI-SF Pain Score
|
-0.32 units on a scale
Standard Error 0.139
|
0.14 units on a scale
Standard Error 0.285
|
|
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
BPI-SF Interference Score
|
-0.28 units on a scale
Standard Error 0.147
|
0.65 units on a scale
Standard Error 0.302
|
SECONDARY outcome
Timeframe: From enrollment to up to approximately 25 weeksPopulation: ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
Outcome measures
| Measure |
Rucaparib
n=136 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
n=36 Participants
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
|
2.4 units on a scale
Standard Error 1.23
|
1.8 units on a scale
Standard Error 2.39
|
SECONDARY outcome
Timeframe: From enrollment to week 5 of dosingPopulation: Safety Population with at least 1 PK sample collected.
Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented.
Outcome measures
| Measure |
Rucaparib
n=228 Participants
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
|---|---|---|
|
Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling
|
1310 ng/mL
Interval 5.5 to 4180.0
|
—
|
Adverse Events
Rucaparib (Treatment Phase)
Serious events: 81 serious events
Other events: 270 other events
Deaths: 6 deaths
Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase)
Serious events: 36 serious events
Other events: 127 other events
Deaths: 3 deaths
Rucaparib (Cross-over Phase)
Serious events: 18 serious events
Other events: 67 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Rucaparib (Treatment Phase)
n=270 participants at risk
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase)
n=130 participants at risk
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
|
Rucaparib (Cross-over Phase)
n=70 participants at risk
Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase.
After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
9/270 • Number of events 9 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
6.2%
8/130 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Angina pectoris
|
1.1%
3/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Cardiac failure
|
0.74%
2/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Eye disorders
Retinal detachment
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Constipation
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
3/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Nausea
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Stomatitis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Vomiting
|
0.37%
1/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Asthenia
|
0.37%
1/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Death
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Fatigue
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
General physical health deterioration
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Non-cardiac chest pain
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Oedema peripheral
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Pain
|
0.37%
1/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Pyrexia
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Blastocystis infection
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Bronchitis
|
1.1%
3/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
COVID-19
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.5%
2/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Campylobacter infection
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Cellulitis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Dermo-hypodermitis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Device related infection
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Infection
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Pneumonia
|
3.0%
8/270 • Number of events 8 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Respiratory tract infection
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Sepsis
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.5%
2/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
7/270 • Number of events 10 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Urosepsis
|
1.1%
3/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Injury, poisoning and procedural complications
Fall
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Blood creatinine increased
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Neutrophil count decreased
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
5/270 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.5%
2/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of eyelid
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.74%
2/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Dizziness
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Neuralgia
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Sacral radiculopathy
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Seizure
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.5%
2/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Syncope
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.74%
2/270 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
8/270 • Number of events 9 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Renal and urinary disorders
Haematuria
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Renal and urinary disorders
Urinary retention
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
1/270 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.5%
2/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
5/270 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.1%
4/130 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Vascular disorders
Orthostatic hypotension
|
0.37%
1/270 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/270 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
Other adverse events
| Measure |
Rucaparib (Treatment Phase)
n=270 participants at risk
Oral rucaparib (monotherapy).
Rucaparib: Rucaparib will be administered daily.
|
Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase)
n=130 participants at risk
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
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Rucaparib (Cross-over Phase)
n=70 participants at risk
Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase.
After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
|
|---|---|---|---|
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Blood and lymphatic system disorders
Anaemia
|
44.8%
121/270 • Number of events 435 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
18.5%
24/130 • Number of events 30 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
37.1%
26/70 • Number of events 90 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.3%
17/270 • Number of events 37 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.6%
6/130 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.7%
4/70 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.9%
24/270 • Number of events 44 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.6%
6/70 • Number of events 8 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
21/270 • Number of events 23 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.7%
10/130 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
15/270 • Number of events 15 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.3%
3/130 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Constipation
|
28.1%
76/270 • Number of events 101 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
14.6%
19/130 • Number of events 23 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
17.1%
12/70 • Number of events 16 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.5%
85/270 • Number of events 118 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
27.7%
36/130 • Number of events 49 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
14.3%
10/70 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
18/270 • Number of events 25 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.8%
5/130 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Nausea
|
50.7%
137/270 • Number of events 222 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
19.2%
25/130 • Number of events 44 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
37.1%
26/70 • Number of events 41 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Stomatitis
|
4.4%
12/270 • Number of events 20 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.7%
10/130 • Number of events 15 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
65/270 • Number of events 98 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.5%
11/130 • Number of events 16 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
17.1%
12/70 • Number of events 25 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Asthenia
|
21.5%
58/270 • Number of events 136 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
15.4%
20/130 • Number of events 36 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
12.9%
9/70 • Number of events 12 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Fatigue
|
43.3%
117/270 • Number of events 203 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
48.5%
63/130 • Number of events 123 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
32.9%
23/70 • Number of events 41 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Oedema peripheral
|
20.4%
55/270 • Number of events 70 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
16.2%
21/130 • Number of events 29 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
20.0%
14/70 • Number of events 15 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
General disorders
Pyrexia
|
5.6%
15/270 • Number of events 17 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.4%
7/130 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.6%
6/70 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
COVID-19
|
5.9%
16/270 • Number of events 17 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.8%
5/130 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
20/270 • Number of events 29 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.3%
3/130 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
10.0%
7/70 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.1%
11/270 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.4%
7/130 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
15/270 • Number of events 22 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.6%
6/130 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Alanine aminotransferase increased
|
24.8%
67/270 • Number of events 146 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.3%
3/130 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
27.1%
19/70 • Number of events 44 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Aspartate aminotransferase increased
|
24.1%
65/270 • Number of events 120 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.1%
4/130 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
28.6%
20/70 • Number of events 46 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.3%
17/270 • Number of events 19 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.5%
2/130 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Blood bilirubin increased
|
4.8%
13/270 • Number of events 43 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
10.0%
7/70 • Number of events 17 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Blood creatinine increased
|
20.4%
55/270 • Number of events 97 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.6%
6/130 • Number of events 8 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
11.4%
8/70 • Number of events 10 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Lymphocyte count decreased
|
4.1%
11/270 • Number of events 27 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.4%
7/130 • Number of events 10 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.7%
4/70 • Number of events 9 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Neutrophil count decreased
|
6.3%
17/270 • Number of events 64 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.8%
5/130 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.7%
4/70 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Platelet count decreased
|
10.7%
29/270 • Number of events 103 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.7%
4/70 • Number of events 20 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
Weight decreased
|
14.8%
40/270 • Number of events 65 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
11.5%
15/130 • Number of events 21 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
14.3%
10/70 • Number of events 18 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Investigations
White blood cell count decreased
|
6.7%
18/270 • Number of events 52 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.3%
3/130 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
10.0%
7/70 • Number of events 27 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.7%
99/270 • Number of events 139 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
22.3%
29/130 • Number of events 43 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
25.7%
18/70 • Number of events 27 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
9/270 • Number of events 9 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.3%
3/130 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.7%
4/70 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.3%
17/270 • Number of events 51 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.1%
4/130 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 16 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.4%
12/270 • Number of events 16 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.7%
10/130 • Number of events 17 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.0%
19/270 • Number of events 34 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.4%
7/130 • Number of events 13 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.3%
52/270 • Number of events 69 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
21.5%
28/130 • Number of events 41 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
12.9%
9/70 • Number of events 11 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.1%
65/270 • Number of events 97 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
20.0%
26/130 • Number of events 31 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
18.6%
13/70 • Number of events 19 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
15/270 • Number of events 19 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.1%
4/130 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.8%
13/270 • Number of events 15 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.1%
4/130 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.7%
4/70 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
16/270 • Number of events 20 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.6%
6/130 • Number of events 8 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.6%
6/70 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.6%
26/270 • Number of events 29 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.5%
11/130 • Number of events 15 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.1%
5/70 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
14/270 • Number of events 15 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
6.9%
9/130 • Number of events 10 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.6%
34/270 • Number of events 48 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
10.8%
14/130 • Number of events 18 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
11.4%
8/70 • Number of events 17 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Dizziness
|
13.7%
37/270 • Number of events 44 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.5%
11/130 • Number of events 12 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.6%
6/70 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
45/270 • Number of events 48 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
13.8%
18/130 • Number of events 22 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
10.0%
7/70 • Number of events 8 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Headache
|
11.5%
31/270 • Number of events 42 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
6.9%
9/130 • Number of events 10 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.1%
5/70 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.3%
9/270 • Number of events 9 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
13.8%
18/130 • Number of events 20 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
8/270 • Number of events 8 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.5%
11/130 • Number of events 16 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Nervous system disorders
Taste disorder
|
2.6%
7/270 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.4%
7/130 • Number of events 8 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Psychiatric disorders
Insomnia
|
8.1%
22/270 • Number of events 23 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
10.8%
14/130 • Number of events 16 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
15/270 • Number of events 17 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
6.2%
8/130 • Number of events 9 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.7%
4/70 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
5/270 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.77%
1/130 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.1%
5/70 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
27/270 • Number of events 28 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
13.1%
17/130 • Number of events 17 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
11.4%
8/70 • Number of events 10 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
45/270 • Number of events 66 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
11.5%
15/130 • Number of events 21 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.6%
6/70 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
6/270 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
5.4%
7/130 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
1.4%
1/70 • Number of events 1 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
5/270 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
20.0%
26/130 • Number of events 28 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.5%
23/270 • Number of events 24 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.7%
10/130 • Number of events 12 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
10.0%
27/270 • Number of events 39 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
0.00%
0/130 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.6%
6/70 • Number of events 7 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
22/270 • Number of events 24 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.8%
5/130 • Number of events 9 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.9%
2/70 • Number of events 2 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
19/270 • Number of events 27 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
3.1%
4/130 • Number of events 4 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.1%
5/70 • Number of events 6 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Vascular disorders
Hot flush
|
6.3%
17/270 • Number of events 18 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
2.3%
3/130 • Number of events 5 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
4.3%
3/70 • Number of events 3 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
|
Vascular disorders
Hypertension
|
6.7%
18/270 • Number of events 36 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
8.5%
11/130 • Number of events 16 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
7.1%
5/70 • Number of events 15 • From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
- Publication restrictions are in place
Restriction type: OTHER